An Overview of Oncology FDA Approvals: Summer 2021


Multiple cancer drugs have been approved by the FDA in the last few months.

Recent FDA approvals

Patients with cancer have more treatment options than ever before, and the Food and Drug Administration (FDA) continues to review and approve more. Here’s an overview of oncology regimens that most recently hit the market this summer.

  • Keytruda plus chemotherapy for triple-negative breast cancer. Keytruda (pembrolizumab) is an immunotherapy agent that was granted approval to be used in combination with chemotherapy (carboplatin and paclitaxel then doxorubicin or epirubicin and cyclophosphamide) for patients with high-risk, early-stage triple negative breast cancer. The trial that led to the approval showed that the drug regimen led to a 37% decrease in the risk of disease progression before definitive surgery, local or distant recurrence, another cancer or death.
  • Darzalex Faspro for myeloma. Darzalex Faspro (daratumumab and hyaluronidase-fihj) plus pomalidomide and dexamethasone was approved to treat patients with myeloma who had at least one prior line of therapy. In the APOLLO study – whose findings were the basis of the approval – there was a 37% improvement of progression-free survival for patients on Darzalex Faspro compared to pomalidomide and dexamethasone.
  • Padcev for pretreated or metastatic bladder cancer. Padcev (enfortumab vedotin-ejfv) was approved for patients with locally advanced or metastatic urothelial carcinoma who previously had immunotherapy and chemotherapy and are not eligible for cisplatin-containing chemotherapy. Patients on Padcev had an overall survival of nearly 13 months, compared to those just given chemotherapy in the EV-301 trial.
  • Rybrevant for non-small cell lung cancer. The FDA approved Rybrevant (amivantamab-vmjw) for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations, and is the first bispecific antibody – and the first regimen to show clinical activity in this group of patients.
  • Rylaze for leukemia and lymphoma. Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn) was approved as a chemotherapy component for adults and pediatric patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who are allergic to E. coli-delivered asparaginase products, curbing a global shortage of other FDA-approved drugs for this patient population.

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