During the past week the FDA approved a host of drugs and approved expanded use of a companion diagnostic. Among the announcements:
- Merck’s PD-1 checkpoint inhibitor pembrolizumab (Keytruda) was greenlighted for the treatment of advanced cervical cancer in women whose disease has progressed on or after chemotherapy and whose tumors express PD-L1. The approval was based on findings of a study in which 77 patients with PD-L1 levels of at least 1% had an overall response rate (ORR) of 14.3%; of those women, nearly all responded to the drug for at least 6 months.
- In conjunction with that pembrolizumab approval, the agency OK’d the expanded use of Agilent’s PD-L1 IHC 223C pharmDx Kit to determine PD-L1 status.
- Pembrolizumab was also approved for the treatment of primary mediastinal large B-cell lymphoma in adults and children, as well as those who have relapsed following at least two other treatments. The decision was based on a phase III trial in which patients treated with the immunotherapeutic had an ORR of 45%.
- Genentech’s bevacizumab (Avastin) plus chemotherapy, followed by bevacizumab monotherapy, was approved for women with advanced ovarian cancer after surgery. In a phase III trial, patients who received that regimen had a median progression-free survival (PFS) of 18.2 months and a median overall survival (OS) of 43.8 months, compared with a PFS of 12.8 months and an OS of 40.6 months in patients who received the combination followed by a placebo.
- The agency also expanded the indication for venetoclax (Venclexta; AbbVie and Genentech). It can now be used with rituximab for second-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with or without a 17p deletion. Patients who received this combination regimen as part of a phase III trial had an ORR of 92% and did not reach median PFS, compared with an ORR of 72% and a PFS of 18.1 months in patients who received bendamustine plus rituximab.