Merck & Co is withdrawing the US indication for pembrolizumab (Keytruda) for metastatic tiny mobile lung most cancers (SCLC) in sufferers with disease development on or just after platinum-centered chemotherapy and at the very least a single other prior line of therapy, according to a company statement.
The shift does not have an effect on any of the drug’s other indications: the immunotherapy is applied in the procedure of quite a few distinct sorts of cancer.
The SCLC indicator experienced been granted an accelerated acceptance by the Foodstuff and Drug Administration (Fda) in 2019 dependent on tumor response amount and longevity of reaction info from client cohorts in two trials. However, the anti-PD-1 remedy failed to reveal statistically sizeable enhanced in general survival in a confirmatory demo, which is mandated soon after an accelerated approval.
The Fda is conducting “an sector-wide analysis of indications primarily based on accelerated approvals that have not yet achieved their publish-marketing and advertising demands,” explained Merck.
Three weeks ago, an indication for durvalumab (Imfinzi) was withdrawn by AstraZeneca in live performance with the Food and drug administration just after the drug failed to make improvements to general survival in unresectable metastatic bladder most cancers in a confirmatory demo, as claimed by Medscape Clinical Information.
“We will continue to rigorously appraise the positive aspects of [pembrolizumab] in smaller mobile lung most cancers and other styles of most cancers, in pursuit of Merck’s mission to preserve and improve life,” said Roy Baynes, MD, main healthcare officer, Merck Study Laboratories, in the firm assertion
Baynes also championed the value of accelerated approvals.
“The accelerated pathways created by the Fda have been integral to the amazing development in oncology treatment in excess of the past 5 yrs and have helped a lot of most cancers clients with highly developed disease, such as compact cell lung cancer, accessibility new treatment plans,” he commented.
Nevertheless, in the past, the Fda has been criticized for approving new cancer medication centered on surrogate markers these as response premiums simply because, in a lot of cases, subsequent scientific tests generally clearly show that the drug fails to increase total survival.
For case in point, a 2015 review uncovered that 36 of 54 (67%) cancer drug approvals from 2008 to 2012 ended up produced on the basis of surrogate markers — both tumor response amount or development-free of charge survival. In excess of a median follow-up period of 4.4 many years, only 5 of those 36 medications were being demonstrated, in randomized studies, to enhance overall survival, as noted by Medscape Health care News.
The Fda claims that it instituted the accelerated approval system to “allow for for previously approval of prescription drugs that treat serious situations, and that fill an unmet clinical need based on a surrogate endpoint.” The program was started out in 1992, in the midst of the HIV/AIDS epidemic.
Past 12 months, the nonprofit Good friends of Most cancers Research issued a white paper contacting for reform in the accelerated acceptance approach, which bundled a proposal to add danger evaluation to surrogate endpoints that would element in variables these types of as toxicity.
Nick Mulcahy is an award-profitable senior journalist for Medscape. He earlier freelanced for HealthDay, MedPageToday and has experienced bylines on WashingtonPost.com, MSNBC, and Yahoo. Email: [email protected] and on Twitter: @MulcahyNick