History is made: FDA approves Merck's PD-1 inhibitor Keytruda for melanoma
- The FDA has approved Keytruda for the secondary treatment of melanoma after patients have failed therapy with Bristol-Myers Squibb’s Yervoy (ilipimumab).
- Keytruda will cost roughly $12,000 per month and require an average treatment time of six months.
- Keytruda is the first-ever PD-1 inhibitor approved by the FDA.
Earlier this week, Biopharma Dive asked, “Does this month mark the beginning of a new era in cancer care?” The answer: Yes. And faster than we thought.
But while there is widespread excitement about a new era of immunotherapy in which PD-1 inhibitors are available as relatively benign treatments that exert a powerful immune-boosting therapeutic effect, the issue of price promises to be contentious. In addition to the baseline 6-month, $75,000 cost of Keytruda, the treatment equation must include the costs of Yervoy and Zelboraf/Tafinlar (vemurafanib/dabrafenib) -- bringing total treatment costs as high as $150,000 for a patient with advanced melanoma.
Merck's ultimate goal, of course, is to advance Keytruda to first-line treatment status. Currently, second-line treatment requires previous treatment with Yervoy, and if a patient has a specific gene mutation -- BRAF V600 -- previous treatment with both Yervoy and either Roche’s Zelboraf or GSK’s Tafinlar is required.
Despite these restrictions, today is a big day as the field of oncologic immunotherapy takes a huge leap forward. And there’s more to come. Not only are other companies' PD-1 drugs advancing rapidly through the approval process -- Merck is studying the use of Keytruda in more than 30 different types of cancer.
- pharmafile.com Merck surprise winner in PD-1 race