Table 1.

Diversity PMR or PMC issued by FDA in oncology between January 2020 and December 2021.

Generic name	Approval date	Indication	Accelerated or traditional	PMR or PMC	Diversity PMR or PMC wording
Tafasitamab	7/31/20	Diffuse large B-cell lymphoma	Accelerated	PMR	Submit the final report and datasets from a randomized, phase III clinical trial to verify the clinical benefit of tafasitamab in patients with diffuse large B-cell lymphoma. The trial should include sufficient numbers of racial and ethnic minority patients to better reflect the US patient population and allow for the interpretation of the results in these patient populations. Patients should be randomized to receive immunotherapy and/or chemotherapy with or without tafasitamab and lenalidomide. The primary endpoint should be progression-free survival, with secondary endpoints that include overall survival and objective response rate.
Umbralisib	2/5/2021	Marginal zone lymphoma and follicular lymphoma	Accelerated	PMR	Conduct a randomized, phase III clinical trial that verifies and describes the clinical benefit of umbralisib in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma. The trial should include sufficient numbers of racial and ethnic minority patients to better reflect the US patient population and allow for interpretation of the results in these patient populations. Patients should be randomized to receive immunotherapy with or without umbralisib. The primary endpoint should be progression-free survival, with secondary endpoints that include overall survival and objective response rate
Melphalan ­flufenamide	2/26/2021	Multiple myeloma	Accelerated	PMR	Submit an integrated final report containing data from clinical trials including trial OP-108 to further characterize the exposure of melphalan flufenamide, the increased risk of serious adverse events including hematologic toxicities, and efficacy among US racial and ethnic minorities including Black patients with relapsed or refractory multiple myeloma. Provide the pharmacokinetic analysis in the interim report.
Idecabtagene ­vicleucel	3/26/2021	Multiple myeloma	Regular	PMC	Celgene commits to submit an integrated final report containing data from clinical trials MM-002 and MM-003 to further characterize the safety and efficacy of idecabtagene vicleucel among African-Americans/Blacks with multiple myeloma. The primary objective of this analysis is to evaluate the efficacy of idecabtagene vicleucel in the subpopulation of African-Americans/Blacks with multiple myeloma compared to the subpopulation of Whites, and the secondary objective is safety. Ensure that the representation of the African American subpopulation in the studies is reflective of the Black population in the geographical location/country. Therefore, approximately 15% of the population that is enrolled from the US should comprise of African Americans. Prespecify an analysis plan for safety and efficacy with a justification/rationale of prespecified assumptions for efficacy outcomes.
Isatuximab-irfc	3/31/2021	Multiple myeloma	Regular	PMC	Submit a final report containing data from clinical trials, post–marketing reports, compassionate use/expanded access programs, real–world evidence, and other sources to further characterize the safety and efficacy of isatuximab in combination with carfilzomib and dexamethasone (Isa-Kd) among US racial and ethnic minority patients with multiple myeloma.
Loncastuxumab tesirine-lpyl	4/23/2021	B-cell lymphoma	Accelerated	PMR	Submit an integrated final report containing data from clinical trials to further characterize the exposure of loncastuximab tesirine-lpyl monotherapy and in combination with immunochemotherapy, the increased risk of severe and serious adverse events, including severe neutropenia, and efficacy among US racial and ethnic minority patients with large B-cell lymphoma. Provide the population pharmacokinetic and exposure-response analyses for both efficacy and safety in the interim report.
Amivantamab-vmjw	5/21/2021	Non-small cell lung cancer	Accelerated	PMC	Submit a final report containing data from clinical trials enrolling a sufficient representation of Black or African American patients that is reflective of the US population of patients with EGFR exon 20 insertion mutated NSCLC to further characterize the safety and efficacy of amivantamab-vmjw in Black or African American patients with EGFR exon 20 insertion mutated NSCLC.
Sotorasib	5/28/2021	Non–small cell lung cancer	Accelerated	PMC	Submit a final report containing data from clinical trials enrolling a sufficient representation of African American patients that is reflective of the US population of patients with KRAS G12C mutated non-small cell lung cancer to further characterize the safety and efficacy of sotorasib in African American patients with KRAS G12C mutated non-small cell lung cancer.
Infigratinib	5/28/2021	Cholangiocarcinoma	Accelerated	PMR	Conduct a clinical trial to further characterize the serious adverse reactions of hyperphosphatemia and eye disorders in patients with firstline or refractory cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement receiving alternate dosage(s) regimens of infigratinib. Characterize all serious adverse events including hyperphosphatemia and eye disorders, dose reductions, interruptions, and discontinuations due to serious adverse events. Compare clinical efficacy and safety descriptively across concurrently enrolled, parallel cohorts evaluating the approved infigratinib dosage and an alternate dosage regimen. Include sparse PK samples for exposure–response analyses for efficacy and safety and conduct exploratory PK/PD analysis using serum phosphate levels. Ensure that racial and ethnic minority subjects are adequately represented in the trial population, at a minimum, proportional to the prevalence of FGFR2 alterations in these subgroups in the US population.
Daratumumab and hyaluronidase-fihj	7/9/2021	Multiple myeloma	Regular	PMR	Conduct a clinical study to further characterize the exposure of daratumumab (D) subcutaneous (SC), the increased risk of severe and serious adverse events, including severe neutropenia, and efficacy among US racial and ethnic minority patients with relapsed or refractory multiple myeloma. Include an assessment of the PK, PD, safety, and efficacy of daratumumab SC in combination with other agents including pomalidomide and dexamethasone (Pd) in US racial and ethnic minority patients including Black and Asian patients with relapsed or refractory multiple myeloma in the final study report. The population pharmacokinetic and exposure–response analyses for both efficacy and safety should be updated.
Daratumumab and hyaluronidase-fihj	7/9/2021	Multiple myeloma	Regular	PMC	Submit a final report containing data from clinical trials, post–marketing reports, compassionate use/expanded access programs, real–world evidence, and other sources to further characterize the safety and efficacy of daratumumab (SC) in combination with pomalidomide and dexamethasone among US racial and ethnic minority patients with multiple myeloma.
Zanubrutinib	8/31/2021	Waldenstrom’s macroglobulinemia	Regular	PMC	Conduct a study to further characterize the clinical benefit and safety of zanubrutinib for the treatment of patients with newly diagnosed Waldenström’s Macroglobulinemia with MYD88 mutation. This should include an assessment of the CXCR4 mutation status. In addition, the study should include a sufficient number of patients enrolled in the United States and sufficient numbers of racial and ethnic minority patients to allow for the interpretation of the results in these patient populations. 2. Conduct a study to further characterize the clinical benefit and safety of zanubrutinib in patients with newly diagnosed and relapsed/refractory Waldenström’s macroglobulinemia with MYD88wt. This study should include a sufficient number of patients enrolled in the United States and sufficient numbers of racial and ethnic minority patients to allow for the interpretation of the results in these patient populations. 3. Conduct an integrated analysis containing data from clinical trials and other data sources such as post–marketing reports, real–world evidence and other sources to further characterize the safety and efficacy of zanubrutinib in racial and ethnic minorities with Waldenström’s macroglobulinemia.
Zanubrutinib	9/14/2021	Marginal zone lymphoma	Accelerated	PMR	Conduct a randomized clinical trial that verifies and describes the clinical benefit of zanubrutinib in patients with relapsed or refractory marginal zone lymphoma. The trial should include sufficient representation of racial and ethnic minorities to better reflect the US patient population and allow for interpretation of the results in these patient populations. The primary endpoint should be progression-free survival, with secondary endpoints that include objective response rate and overall survival.
Mobocertinib	9/15/2021	Non–small cell lung cancer	Accelerated	PMC	Conduct an analysis containing data from clinical trials enrolling a sufficient representation of US racial and ethnic minorities, including Black or African American patients, that is reflective of the US population of patients with EGFR exon 20 insertion–mutated NSCLC
Daratumumab and hyaluronidase-fihj	11/30/2021	Multiple myeloma	Regular	PMC	Conduct an integrated study analysis containing data from clinical trials, post–marketing reports, compassionate use/expanded access programs, real–world evidence, and other sources to further characterize the safety and efficacy of daratumumab (SC) in combination with carfilzomib and dexamethasone among US racial and ethnic minority patients with multiple myeloma.