publication date: Jun. 21, 2019

Drugs & Targets

FDA approves pembrolizumab for metastatic SCLC

FDA has granted accelerated approval to pembrolizumab (Keytruda) for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The drug is sponsored by Merck.

Efficacy was investigated in 83 patients with SCLC who had disease progression on or after two or more prior lines of therapy enrolled in one of two multicenter, multi-cohort, non-randomized, open label trials:

KEYNOTE-158 (NCT02628067) Cohort G;

KEYNOTE-028 (NCT02054806) Cohort C1.

Patients received either pembrolizumab 200 mg intravenously every 3 weeks (n=64) or 10 mg/kg intravenously every two weeks (n=19). Treatment continued until documented disease progression, unacceptable toxicity, or a maximum of 24 months.

The main efficacy outcome measures were overall response rate and duration of response (modified RECIST v1.1) assessed by blinded independent central review. The ORR was 19% (95% CI: 11, 29); the complete response rate was 2%. Responses were durable for 6 months or longer in 94%, 12 months or longer in 63%, and 18 months or longer in 56% of the 16 responding patients.

Adverse reactions in patients who received single-agent pembrolizumab for previously treated SCLC were similar to those occurring in patients with other solid tumors who received pembrolizumab.

Pembrolizumab was previously granted orphan drug designation and priority review for the SCLC indication.


FDA approves Amgen and Allergan’s Kanjinti, Herceptin biosimilar

FDA approved Amgen and Allergan Kanjinti’s (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab)  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic … Continue reading FDA approves pembrolizumab for metastatic SCLC

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