Abstract
Robust drug-development programs targeting the second most common male cancer (after skin cancer) will help increase U.S. market sales to $3.7 billion by 2023.
Prostate cancer has become the second most common type of cancer affecting men (skin cancer is number one), with approximately 240,000 patients diagnosed each year.1 Their prognosis depends on various factors, such as the stage of the cancer and other patient characteristics, including age, race, and overall health. If prostate cancer is diagnosed early, localized therapies such as prostatectomy and radiotherapy can be used, resulting in a virtual 100% five-year survival rate.2 Unfortunately, the risk of metastases increases as the disease progresses; the most common areas of metastases are the adrenal gland, bone, liver, and lung.3 A poorer prognosis results as the cancer advances, with a five-year survival rate of 37%.2
Traditionally, chemotherapy was the mainstay of treatment for metastatic prostate cancer. Docetaxel was the primary agent because it improved overall survival (OS), but its unfavorable toxicity profile has since relegated it to later-line therapy. Since 2010, multiple hormone therapies have been approved and have become favored options for the treatment of metastatic prostate cancer. They fall into different drug categories and have contributed to overall U.S. market sales estimated at $1.6 billion in 2013.3,4
The pipeline is filled with exciting therapies designed with various mechanisms of action. As physicians continue to gain experience with newer therapies, the reception for future drugs should be positive. With the robust pipeline and efficacious current agents, overall market sales are expected to grow to $3.7 billion in the U.S. by 2023.4
Future Therapies
|
Drug
Manufacturer |
Status | Regimen Information | Pivotal Studies | Expected Approval | Anticipated Peak Year Sales/Pricing |
|---|---|---|---|---|---|
| Yervoy (ipilimumab) Bristol-Myers Squibb |
Phase 3 | 10 mg/kg IV every three weeks for four times, then once every 12 weeks | NCT01057810 | 2016 | Anticipated pricing similar to current Yervoy melanoma pricing, despite increased dose; U.S. sales expected to reach $210 million by 2023 |
| Custirsen sodium OncoGenex |
Phase 3 | 1,920-mg IV loading dose followed by 640 mg IV weekly | AFFINITY | 2016 | Anticipated pricing competitive with Zytiga; U.S. sales expected to reach $182 million by 2023 |
| ProstVac (vaccinia-PSA-TRICOM/fowlpox-PSA-TRICOM) Bavarian Nordic |
Phase 3 | SC injection of ProstVac-V-TRICOM at week 1; six injections of ProstVac-F-TRICOM at weeks 3, 5, 9, 13, 17, 21 | PROSPECT | 2017 | Anticipated pricing at a 30% discount to Provenge; U.S. sales expected to reach $140 million by 2023 |
| Tasquinimod Active BioTech/Ipsen |
Phase 3 | 0.25 mg, 0.5 mg, or 1.0 mg orally once daily | NCT01234311 | 2017 | Anticipated pricing competitive with Xtandi; U.S. sales expected to reach $101 million by 2023 |
| ARN-509 Johnson & Johnson |
Phase 3 | 240 mg orally once daily | SPARTAN | 2017 | Anticipated pricing competitive with Xtandi; U.S. sales expected to reach $152 million by 2023 |
| ProstAtak Advantagene |
Phase 3 | 1st dose 15 days before radiotherapy; 2nd dose 0–3 days before radiotherapy; 3rd dose 15–22 days after 2nd dose | NCT01436968 | 2018 | Anticipated pricing at a 30% discount to Provenge; U.S. sales expected to reach $503 million by 2023 |
| ODM-201 Bayer |
Phase 3 | 300 mg orally twice daily | NCT02200614 | 2019 | Anticipated pricing competitive with Xtandi; U.S. sales expected to reach $35 million by 2023 |
| DCVAC/PCa Sotio |
Phase 3 | 10 doses of dendritic cells (1 × 107 cells) injected SC every six weeks | NCT02111577 | 2019 | Anticipated pricing competitive with Provenge; U.S. sales of $42 million in 2023 |
IV = intravenous; SC = subcutaneous
Sources: FDA; GlobalData; company websites; ClinicalTrials.gov
Current Therapiesa
|
Drug Manufacturer |
Approval Date | Indicationb | Regimen Informationc | Cost of Course of Therapy per Monthd |
|---|---|---|---|---|
| Targeted Therapies | ||||
| Xofigo (radium 223 dichloride) Bayer |
May 15, 2013 | Metastatic castration-resistant prostate cancer | 1.35 microcuries per kilogram of body weight injected every four weeks for six injections | $14,391e,f |
| Xtandi (enzalutamid) Astellas |
August 31, 2012 | Metastatic castration-resistant prostate cancer | 160 mg (four 40-mg capsules) orally once daily | $10,618 |
| Zytiga (abiraterone acetate) Johnson & Johnson |
April 28, 2011 | Metastatic castration-resistant prostate cancer | 1,000 mg (four 250-mg tablets) orally once daily | $9,595 |
| Chemotherapies | ||||
| Jevtana (cabazitaxel) Sanofi |
June 17, 2010 | Hormone-refractory metastatic prostate cancer | 25 mg/m2 one-hour IV infusion every three weeks | $5,813g |
| Therapeutic Vaccines | ||||
| Provenge (sipuleucel-T) Dendreon |
April 29, 2010 | Metastatic castration-resistant prostate cancer | Three doses at two-week intervals | $91,769f |
| Hormone Therapies | ||||
| Firmagon (degarelix) Ferring |
December 29, 2008 | Advanced prostate cancer | 240-mg SC starting dose, then 80 mg every 28 days | Starting dose, $1,659; maintenance, $553 |
| Eligard (leuprolide acetate) Sanofi/Astellas |
December 16, 2004 | Palliative treatment of advanced prostate cancer | 7.5 mg SC every month | $493 |
| Trelstar (triptorelin acetate) Actavis |
June 15, 2000 | Palliative treatment of advanced prostate cancer | 3.75 mg IM every four weeks | $976f |
| Zoladex (goserelin acetate) AstraZeneca |
July 28, 1998 | Stage B2-C prostatic carcinoma, prostatic carcinoma | 3.6 mg SC every 28 days | $601f |
| Casodex (bicalutamide) AstraZeneca |
October 4, 1995 | D2 metastatic carcinoma of the prostate | 50 mg orally once daily | $630 |
| Lupron Depot (leuprolide acetate) AbbVie |
January 26, 1989 | Palliative treatment of advanced prostatic cancer | 7.5 mg IM every four weeks | $1,401f |
This list is not all-inclusive; additional therapies may be available for this disease state.
Abbreviated indication provided; for full indication, please refer to prescribing information.
Regimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.
Costs calculated using average wholesale price and regimen provided for 30 days (unless otherwise noted), rounded to the nearest dollar.
80.7 kg used as average U.S. male’s weight.
Price was calculated for a four-week dose.
Price was calculated for a three-week dose, using 1.9 m2 as the average U.S. male’s body surface area.
IM = intramuscular; IV = intravenous; SC = subcutaneous
Sources: Red Book; Drugs@FDA; and prescribing information for all medications
REFERENCES
- 1. CancerCare. Treatment update: metastatic prostate cancer. Available at: http://www.cancercare.org/publications/180-treatment_update_metastatic_prostate_cancer. Accessed July 10, 2015.
- 2.GlobalData. Prostate Cancer—Global Drug Forecast and Market Analysis to 2023. Apr, 2015.
- 3.National Cancer Institute Metastatic cancer. Mar, 2013. Available at: http://www.cancer.gov/about-cancer/what-is-cancer/metastatic-fact-sheet. Accessed July 10, 2015.
- 4. Decision Resources. Driven by the launches of promising emerging therapies, the prostate cancer drug market will experience robust growth over the next decade, increasing from $3.6 billion in 2010 to $10.1 billion in 2020. November 2011. Available at: http://decisionresources.com/News-and-Events/Press-Releases/Prostate-Cancer-110711. Accessed July 10, 2015.