A Comprehensive Overview of US-FDA-Approved Anticancer Drugs and Biologics in 2023: An Observational Study

Abstract

Background:

The United States Food and Drug Administration (US FDA) is responsible for ensuring public health by conducting a comprehensive assessment and approval of pharmaceuticals, medical devices, and food products. The federal agency conducts a thorough evaluation of drug safety and efficacy before granting market approval.

Materials and Methods:

This retrospective study aimed to analyze all new drug approvals that took place during the 2023 study period using an observational, record-based approach. To gather data on drug approvals by the US FDA, we relied on the FDA database website. We also conducted a literature search on electronic databases like PubMed, ClinicalTrials.gov, and the Cochrane Database to gather comprehensive drug-related information.

Results:

In the calendar year (CY) 2023, a total of 55 drugs were approved by the US-FDA, out of which 23 drugs (42%) were given orphan drug designation, and 12 drugs (22%) were approved in the first-in-class category during this period. The US-FDA granted 7 breakthrough approvals, 22 priority approvals, 18 fast track approvals, 2 qualified infectious disease product designations, and 4 accelerated approvals in CY 2023. There were 16 drugs (29%) that were approved for cancer in 2023 by the US FDA. Out of the 16 drugs, 6 belonged to the tyrosine kinase class, 6 were monoclonal antibodies, and 1 each was a gamma secretase inhibitor and an estrogen receptor antagonist. During CY 2023, 16 (29%) biological drugs were approved, which included monoclonal antibodies, (n = 12), enzymes derivatives (n = 3), and hormones derivatives (n = 1).

Conclusion:

Notable advancements in the drug development market were witnessed between 2015 and 2022, and 2023 was no different. The total number of novel drugs approved was significantly higher than the previous year. Expedited approval of anticancer drugs and biologics is seen as a recent trend in drug development.

INTRODUCTION

The United States Food and Drug Administration (US FDA) ensures the safety of pharmaceuticals, medical devices, and food products. It evaluates their efficacy before granting market authorization. The agency is a part of the Department of Health and Human Services and plays a crucial role in maintaining the quality of various products that impact millions of lives worldwide.[1] The FDA ensures innovation and safety through a thorough review process that includes preclinical studies, clinical trials, and post-market monitoring. It also collaborates with industry, academia, and international regulatory entities to advance medical and scientific understanding of global health challenges.[2] The FDA’s Center for Drug Evaluation and Research (CDER) provides guidance to drug developers during the process of developing new drugs and therapeutic biological products. The guidance clarifies the essential study design elements and additional data needed in the drug application to support a full and comprehensive assessment. CDER relies on its understanding of the scientific methodologies used in developing new products, as well as the testing and manufacturing processes, and the diseases and conditions for which these new products are intended.[3] Each year, a wide variety of novel pharmaceuticals and biological products, some of which have never been employed in clinical practice, are approved by the CDER. A number of novel drugs were granted approval by the US FDA last year, an indication of notable advancements in medical innovation.[4] During FDA review, certain drugs are classified as novel molecular entities. Many of these compounds contain active ingredients that the FDA has not yet approved, either as stand-alone drugs or as parts of combination treatments. These products frequently provide patients with beneficial new therapy alternatives.[5]

This retrospective observational study aims to comprehensively compile pertinent information on all drugs approved by the US FDA in the year 2023. To the best of our knowledge, no prior study has been done to summarize or identify trends in therapeutics approved during this period. The significance of this research lies in its pioneering effort to fill this knowledge gap, providing a consolidated overview of the pharmaceutical landscape in 2023. By examining and categorizing the approved drugs, this study aims to offer valuable insights into emerging therapeutic trends and contribute to a deeper understanding of the evolving pharmaceutical domain and its intricacies, thereby facilitating informed decision-making and future research endeavors in the field.

MATERIALS AND METHODS

This was a observational, record-based, retrospective study to analyze all new drug approvals during the calendar year (CY) 2023. We obtained information about US FDA new drugs approvals from the FDA database website. A thorough literature search of electronic databases like PubMed, ClinicalTrials.gov, and the Cochrane Database was another way to find extensive drug-related information. A list of all newly approved drugs and products for 2023 was released in the FDA’s annual report from CDER. This list did not include any vaccines, allergy products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved by the Centre for Biologics Evaluation and Research in the same period. The data were analyzed based on several criteria, including the annual approval rate for orphan drugs, first in class approval, drug class, and the type of approval obtained, such as combined accelerated approvals. The anticancer drugs and biologicals that were licensed in 2023 were thoroughly described and categorized. Each drug was extensively searched for its indication, mechanism of action, routes of administration, and pharmacological category. We also conducted an extensive search on types of drug approvals, which includes breakthrough approvals, priority approvals, fast track approvals, qualified infectious disease product designation, and accelerated approvals. In addition to this, orphan drug status, black box warnings, and controlled drugs status was also recorded. Anticancer drugs were classified into three groups: targeted drugs, targeted biologics, and cytotoxic agents. We also analyzed biomarkers or clinical endpoints—progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), and overall survival (OS)—that were used in the pivotal studies for drug approvals. The 2007 version of MS Excel was used to enter and tabulate the data for analysis. Descriptive statistics were employed for the study.

RESULTS

In CY 2023, the US FDA approved a total of 55 new drugs. Among these, 23 drugs were given orphan drug designation, which accounts for 42% of all approved drugs. Additionally, 12 drugs (22%) were approved as first-in-class drugs during this period. The US FDA granted 7 breakthrough approvals, 22 priority approvals, 18 fast track approvals, 2 qualified infectious disease product designations, and 4 accelerated approvals in CY 2023. Furthermore, 2 fixed-dose combinations were approved, and 16 drugs (29%) carried black box warnings on approval. The most commonly prescribed drugs were for cancer (n = 16; 29%), followed by drugs for genetic disorders (n = 13; 23.63%) and endocrine disorders (n = 5; 09%), as shown in Figure 1. While evaluating the drug dosage forms, most of the approved drugs were given by the enteral route (n = 29; 52.72%), followed by the parenteral route (n = 20; 36.36%) and local route (n = 06; 10.90%), as shown in Figure 2. Of the approved medications, almost 96% (n = 53) were approved for the treatment of disorders, one was approved for diagnostics, and one was approved for disease prevention.

Figure 1.

List of indications for all drugs approved by the United States Food and Drug Administration in 2023

Figure 2.

Routes of administration of drugs approved by the United States Food and Drug Administration in 2023

Anticancer drugs

In 2023, the US FDA approved 16 drugs (29%) for the treatment of cancer. Out of these 16 drugs, 6 belong to the tyrosine kinase category, 6 were monoclonal antibodies, and 1 each belongs to a gamma secretase inhibitor and an estrogen receptor antagonist. Of these drugs, 8 are administered orally (6 tablets and 2 capsules) and 8 are given parenterally (4 each by intravenous and subcutaneous route). During this period, 7 drugs were administered with orphan drug designation, and 2 drugs were first-in-class drugs. Of the 16 drugs, 15 were given for treatment, and only 1 drug was approved for the diagnosis of a disease. Furthermore, 13 drugs (81%) were approved by priority review, 13 drugs (81%) were approved by fast-track review, and 9 drugs (56%) were given breakthrough approvals. Among the 16 anticancer drugs, 11 (68%) were designated as orphan drugs. Supplementary Table 1 provides the details of the different anticancer drugs, their mechanism of action, and targets.

Supplementary Table 1.

Summary of details of anticancer drugs approved in 2023

Drugs	Indication	Use of bio/SE/CE in pivotal stage	Treatment/diagnostic	Review and designation
Nirogacestat	Adults with progressing desmoid tumours who require systemic treatment	PFS/ORR	Treatment	Priority review, breakthrough designation, fast track designation, and orphan drug designation
Capivasertib	Breast cancer	PFS	Treatment	Priority review
Repotrectinib	Ros1-positive non-small cell lung cancer	ORR and DOR	Treatment	Priority review, breakthrough designation, and fast track designation
Fruquintinib	Refractory, metastatic colorectal cancer	OS	Treatment	Priority review
Toripalimab-tpzi	Recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies	PFS/OS	Treatment	Priority review, breakthrough designation, and orphan drug designation
Quizartinib	Part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria	OS	Treatment	Priority review, fast track designation, and orphan drug designation
Glofitamab-gxbm	Diffuse large b-cell lymphoma, not otherwise specified, or large b-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy	ORR and DOR	Treatment	Priority review and fast track designation
Flotufolastat f 18	Used in positron emission tomography imaging in certain patients with prostate cancer	-	Diagnosis	Normal review
Epcoritamab-bysp	Relapsed or refractory diffuse large b-cell lymphoma (not otherwise specified) and high-grade b-cell lymphoma after two or more lines of systemic therapy	ORR and DOR	Treatment	Priority review
Retifanlimab-dlwr	Metastatic or recurrent locally advanced Merkel cell carcinoma	ORR and DOR	Treatment	Priority review, fast track, and orphan drug designation
Elacestrant	Estrogen receptor-positive, human epidermal growth factor receptor 2-negative, esr1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy	PFS	Treatment	Priority review and fast track designation
Pirtobrutinib	Relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a btk inhibitor	ORR and DOR	Treatment	Priority review and fast track designation
Momelotinib	Intermediate or high-risk myelofibrosis in adults with anemia	-	Treatment	Normal review
Motixafortide	Used with filgrastim (g-csf) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma	-	Treatment	Normal review
Elranatamab-bcmm	Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy	ORR and DOR	Treatment	Priority review, breakthrough designation, and orphan drug designation
Talquetamab-tgvs	Adults with relapsed or refractory multiple myeloma who have received at least four prior therapies	ORR and DOR	Treatment	Priority review, breakthrough designation, and orphan drug designation

ORR=Overall response rate, DOR=Duration of response, PFS=Progression-free survival, OS=Overall survival

Biological drugs

In CY 2023, a total of 16 biological drugs were approved, which accounted for 29% of all approved drugs. These drugs include monoclonal antibodies (n = 11), enzyme derivatives (n = 3), and hormone derivatives (n = 1). Out of the 12 monoclonal antibodies, 10 were humanized and only 2 were human types. All biological drugs were administered via the parenteral route, with intravenous being the most common (n = 7), followed by subcutaneous (n = 6) and intramuscular (n = 1). Two drugs were given through both intravenous and subcutaneous routes. In the same period, 9 drugs were given orphan drug designation, while 2 were first-in-class drugs. Supplementary Table 2 shows the details of biological drugs, their mechanism of action, and targets.

Supplementary Table 2.

Summary of all biological drugs approved by United States Food and Drug Administration in 2023

Drugs	Indications	Targets	Pharmacological class
Toripalimab-tpzi	Recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies	PD-1	Anticancer drug
Mirikizumab-mrkz	Ulcerative colitis	IL-23	Drugs affecting GIT
Bimekizumab	Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy	IL 17 A, IL17F and IL 17AF	Drugs for skin and mucous membrane
Cipaglucosidase alfa-atga	Late-onset Pompe disease	Recombinant human acid α-glucosidase enzyme replacement therapy	Genetic disorder
Pozelimab-bbfg	Patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease	CD55	Genetic disorder
Elranatamab-bcmm	Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy	Bispecific BCMA-directed CD3 T-cell engager	Anti-cancer drug
Talquetamab-tgvs	Adults with relapsed or refractory multiple myeloma who have received at least four prior therapies	Bispecific GPRC5D-directed CD3 T-cell engager	Anti-cancer drug
Nirsevimab-alip	Prevent respiratory syncytial virus (RSV) lower respiratory tract disease	RSV F proteindirected fusion inhibitor	Antiviral drug
Somatrogon-ghla	Growth failure due to inadequate secretion of endogenous growth hormone	Growth hormone analog	Drug for endocrine disorder
Rozanolixizumab-noli	Generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive	Neonatal Fc receptor	Drugs affecting automonic nervous system
Glofitamab-gxbm	Diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy	Bispecific CD20-directed CD3 T-cell engager	Anti-cancer drug
Epcoritamab-bysp	Relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy	Bispecific CD20-directed CD3 T-cell engager	Anti-cancer drug
Pegunigalsidase alfa-iwxj	Fabry disease	Recombinant human α-galactosidase-A	Genetic disorder
Retifanlimab-dlwr	Metastatic or recurrent locally advanced Merkel cell carcinoma	PD-1	Anti-cancer drug
Velmanase alfa-tycv	Non-central nervous system manifestations of alpha-mannosidosis	Recombinant human lysosomal alpha-mannosidase	Genetic disorder
Lecanemab-irmb	Alzheimer’s disease	Amyloid beta-directed antibody	Drugs affecting central nervous system

PD-1=Programmed death receptor-1, IL=Interleukin, CD55=Complement C5, BCMA=Bispecific B-cell maturation antigen, RSV=Respiratory syncytial virus

DISCUSSION

The FDA was established in 1930 to promote safe and effective drugs. After the 1962 amendments, well-controlled trials became the standard of evidence for evaluating new drugs in terms of efficacy and safety.[6,7] According to studies, the average number of new drugs approved by the FDA annually was 37 between 1994 and 2003. However, from 2004 to 2011, this number decreased to an average of 26 drugs per year. Between 2012 and 2018, an average of 40 new drugs per year were approved.[8,9] From CY 2013 to 2022, an average of 43 new drugs were approved each year.[10] The US FDA approved 55 drugs in 2023, which is the second-highest number of drug approvals in the last 20 years. The highest number of drug approvals was in 2018, with a total of 59. Compared to 2022, the FDA approved nearly 50% more novel drugs in 2023, bringing it back to historical levels. The number of novel drugs approved each year can vary due to multiple factors, including the complexity of new drugs in development and advancements in scientific understanding of diseases and disease targets.[11] The low number of drug approvals can be attributed to the decline in high-quality industry applications and a general drought in industry labs. However, the trend has increased after 2011, which may be due to the fact that the US FDA has lowered some approval standards, particularly for cancer drugs, and has sped up many of its reviews.[12] Moreover, the rise in the number of new pharmaceuticals can be attributed to the new leadership at the FDA and the improved guidance provided to businesses on the information that must be included in a new drug application.[13] Over the years, many of the drugs that have been approved are known as “specialty drugs.” These drugs are usually designed to treat chronic, complex, or rare conditions. They may also require special handling or monitoring of the patients. Most specialty drugs are biologics, which are large-molecule drugs based on living cell lines. Due to their complex nature, they are costly to develop and frequently have high prices. In the past, most drugs were small-molecule drugs based on chemical compounds. Even when under patent, these drugs had lower prices compared to recent specialty drugs.[14]

FIC drugs provide fresh therapeutic choices for treating previously untreatable conditions. According to a study conducted by Shukla et al., from CY 2012–2018, 50% (n = 141) of newly approved drugs were the first of their kind. These drugs offer new treatment options that were previously unavailable.[9] In 2022, CDER approved 37 novel drugs. Of these, 20 (54%) were first-in-class drugs with mechanisms of action different from existing therapies.[15] Our research found that in 2023, only 22% of drugs were FIC, indicating a significant decrease. This decline shows that FIC drugs are not playing their crucial role in public health as they used to. Additionally, our study revealed that 23 new drugs (equivalent to 43%) were designated as orphan drugs in 2023. In contrast, in 2022, 54% (n = 20) of new drugs were approved to treat rare or “orphan” diseases.[16] From CY 2012–2018, 43% of overall drugs were given orphan drug designation.[9]

In 2023, a total of 55 drugs were approved, out of which 16 (30%) were specifically dedicated to anticancer therapies. In comparison, the previous year of 2022 saw the approval of 37 drugs, out of which 12 (31%) were classified as anticancer drugs.[16] The utilization of various biomarkers, regulatory support, and diverse therapeutic indications contribute to the promising future of cancer treatment. In 2023, a diverse range of anticancer drugs was approved to target various malignancies, including breast cancer, colorectal cancer, prostate cancer, and multiple myeloma. Expedited reviews and designations granted by regulatory authorities have marked the progress and addressed critical unmet medical needs. Most of the approved anticancer drugs underwent priority review, emphasizing the urgency and importance attributed to these therapeutic advancements. Additionally, breakthrough designation was given to 56% of the drugs, signifying their potential to revolutionize therapeutic paradigms. The Fast Track Designation was granted to 81% of the approved anticancer drugs, accelerating the development and review of drugs for serious conditions. Furthermore, 68% of the approved drugs received Orphan Drug Designation, intended for treating rare diseases or conditions. This designation is important in the development of therapies for patients with limited treatment options. Cancer therapies have received more fast-track, expedited, and priority approvals from 2000 to 2017 than any other treatment.[17,18,19,20,21] This statistic is quite exciting, as it shows that most of the newly approved drugs are in the field of oncology. It is possible that the constant need for cancer treatments, as well as their past success in receiving accelerated approval based on surrogate endpoints, could have contributed to their recent approval rate.[22] In the study we conducted, it was found that out of all the drugs approved, 94% (n = 15) of the drugs were approved for the treatment of cancer. Meanwhile, only 6% (n = 1) received approval for diagnostic purposes.

The study also discovered that 50% (n = 8) of the anticancer drugs approved were for blood-related tumors, such as leukemia and lymphoma. Meanwhile, 13% each were approved for skin cancer and breast cancer. The findings of our study also coincide with the trend that therapeutic approvals have increased for breast cancer, leukemia, and lymphoma since 2014. Furthermore, approvals for skin and thyroid cancers have also increased after an absence of therapeutic approvals between 2000 and 2010. The majority of FDA approvals between 2010 and 2021 have been for lung cancers, lymphoma, genitourinary cancers, breast cancer, and leukemia.[23]

Anticancer drugs were classified into three product groups: targeted drugs, targeted biologics, and cytotoxic agents. Targeted drugs (kinase inhibitors) had the highest proportion of approvals (31%) among all classes between 2000 and 2021.[23] In 2022, 19% of the novel approved drugs were targeted drugs. In our study, 38% (n = 6) of all anticancer drugs were targeted drugs. The second class, targeted biologics, also called antitumor-associated antigen antibodies, accounted for 25% (n = 4) in 2023, which was higher than the average 10% from 2000 to 2021. The third class was cytotoxic anticancer drugs; in 2023, no drugs (0%) in this class were approved. In 2023, six miscellaneous drugs belonging to other classes were also approved. First, nirogacestat—a gamma secretase inhibitor—was approved for the treatment of adults with progressing desmoid tumors. Second, talquetamab-tgvs, a bispecific GPRC5D-directed CD3 T-cell engager, was approved for the treatment of relapsed or refractory multiple myeloma. Third, elranatamab-bcmm, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, was also approved for the treatment of relapsed or refractory multiple myeloma. The fourth drug, motixafortide, is a hematopoietic stem cell mobilizer and a CXCR4 antagonist approved for the treatment of multiple myeloma in combination with filgrastim (G-CSF), to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. The fifth drug, elacestrant, is an estrogen receptor antagonist approved to treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer. The sixth drug, flotufolastat F 18, was approved for the diagnosis of certain patients with prostate cancer using positron emission tomography imaging.

In 2023, two drugs (4%)—nirogacestat (a gamma secretase inhibitor) and talquetamab-tgvs (a bispecific GPRC5D-directed CD3 T-cell engager)—were approved as first-in-class drugs. Between 2009 and 2020, 37% of drug approvals were for therapies with a new mechanism of action within a specific tumor type. Although the proportion of such approvals declined from approximately 60% in 2009 to 40% in 2020, the absolute number of approvals with a novel mechanism of action increased from 5 to 24 over the same period. However, when evaluating drug approvals across different tumor types, the proportion of drugs with a novel mechanism of action has decreased from approximately 40% to 10%, despite a slight increase in the absolute number of such approvals—from 3 to 7. These findings provide a valuable benchmark for assessing future FDA approvals in an era of rapid drug development. Moreover, they indicate that the significant rise in anticancer drug approvals by the FDA over the past decade has been largely driven by the approval of next-in-class agents and the expansion of indications for existing drugs within the same tumor type.[24]

Biomarkers used to identify certain cancers and cancer subtypes are increasingly guiding drug development and the identification of patients most likely to benefit from treatment. Biomarkers were used in 32% of approvals between 2000 and 2004, 30% between 2005 and 2009, and 43% between 2020 and 2022, respectively.[23] The anticancer drugs that were approved in 2023 followed a pattern similar to previous years. Supplementary Table 1 lists the details of the biomarkers that were used in individual anticancer drugs. The biomarkers or clinical endpoints used in the pivotal studies varied across the approved drugs. Among the studies, PFS was used in 44% (n = 4), followed by ORR in 69% (n = 10), DOR in 31% (n = 6), and OS in 12.5% (n = 2).

During CY 2023, 16 (29%) biological drugs were approved, which included monoclonal antibodies (n = 12;75%) (with n = 11 biosimilars), enzymes derivatives (n = 3;19%), and hormones derivatives (n = 1;6%). The approval trends for biologics in 2023 followed a similar pattern to previous years. Over the past 8 years (2015–2022), an average of 13 biologics per year have been approved, with the highest number (n = 17) approved in 2018 and the lowest number (n = 7) approved in 2016. If we consider the percentage of total biologics approved compared to the total number of drugs approved annually, then between 2015 and 2022, 30% of new approvals were biologics, with the highest percentage (41%) in 2022 and the lowest (25%) in 2016.[25] From 2015 to 2023, most biologic drugs were monoclonal antibodies, with the highest number (n = 12) approved in 2023 and 2020, while the lowest number of antibodies (n = 7) was approved in 2017. In the last 8 years, from 2015 to 2022, an average of 8 orphan biological drugs were approved, with a maximum of 13 in CY 2018 and a minimum of 2 in CY 2016. If we consider the percentage of total orphan drugs from the total biological drugs approved, it was 54% from 2015 to 2022, with a maximum of 76% in 2018 and a minimum of 28% in 2016.[25] In 2023, 56% (n = 9) of drugs were given orphan drug designation.

According to our study in 2023, the most common reasons for using biologics drugs were for anticancer purposes (38%), followed by genetic disorders (25%). Other reasons included treatment for central nervous system disorders, gastrointestinal illnesses, endocrine issues, antiviral conditions, skin disorders, and myasthenia gravis. Supplementary Table 2 provides details of the biological drugs, their mechanism of action, targets, and indications. Additionally, in CY 2022, oncology was the primary indication for approved drugs, followed by dermatology.[25] Cancer has been the primary target for monoclonal antibodies in the biologics market, with a clear growth trend since 2019.

Strength

We have conducted an impartial analysis of the FDA approval data for the year 2023. The data was collected from official documents and objectively analyzed to identify overall trends and compared with previous years. Our analysis provides valuable insights that can be used for future studies to investigate trends over an extended period.

Limitations

We could not analyze the extent of rejections of new drug applications in 2023 due to lack of access to FDA data. Furthermore, we were unable to study the quality of documentation and its clinical impact.

CONCLUSION

Notable advancements were witnessed in the drug development market between 2015 and 2022, and 2023 was no exception. The total number of novel drugs approved was significantly higher than in the previous year. The expedited approval of anticancer drugs and biologics is seen as a recent trend in drug development. Some of the drugs authorized in 2023 targeted diseases and conditions without a specific standard treatment, and they have novel mechanisms of action. This finding reflects the continued efforts to tackle challenges and provide patients with diseases other than cancer more treatment options. Our results suggest that FDA’s existing system of stringent but realistic and need-based drug approvals is a significant step toward speedy drug development. To boost the research and development of novel molecules or drugs that can provide significant improvement over existing ones, the FDA should adopt new approaches that encourage the industry.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.