✦ AstraZeneca said Feb. 22 that it would voluntarily withdraw the Imfinzi (durvalumab) indication in the U.S. for previously treated adults with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The FDA gave the indication accelerated approval on May 1, 2017 (RSP 5/17, p. 10). A confirmatory trial did not meet post-marketing requirements. View the statement at https://bit.ly/3kF92RO.
✦ Merck & Co., Inc. said March 1 that it was voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other line of therapy. The FDA gave the drug accelerated approval on June 18, 2019, for the indication (RSP 7/19, p. 8). The company was required to conduct a post-marketing study to establish superiority of the drug as determined by overall survival. The confirmatory Phase III trial had two primary endpoints; the drug met the progression-free survival endpoint but did not reach statistical significance for the overall survival endpoint. The move comes just a few months after Bristol Myers Squibb said on Dec. 29, 2020, that it was withdrawing the exact same indication for Opdivo (nivolumab) following accelerated approval on Aug. 17, 2018 (RSP 1/21, p. 12). View Merck’s statement at https://bit.ly/2NKEe6t.