Monday, June 8, 2015

Merck Gets Narrow Label (End-Stage) Melanoma Clearance -- In Canada -- for Keytruda®

This morning -- our gentle neighbors to the north are catching up, with their new monoclonal antibody approvals, here. Canada will -- starting today -- allow melanoma patients, already in nearly end stage catharsis, to receive pembrolizumab -- branded as Merck's Keytruda®. To be sure, the anti PD-1L inhibitor has shown strong efficacy in clinical trials, in that subsegment of the US and European oncology wards.

This is good news for Kenilworth, but there is likely to be significant pressure on the reimbursement rates, up north. So. . . I'll notch it as only mildly positive. If memory serves, Nivolumab® (by BMS) is already available in Canada as well. Here's the Merck presser -- and a bit:

. . . .Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor. The product has been approved in Canada under the Notice of Compliance with Conditions (NOC/c) policy on the basis of promising evidence of clinical effectiveness and pending the results of trials to verify its anticipated benefit.

"All of us at Merck Canada are thrilled with Keytruda being available in Canada for the treatment of advanced melanoma, as it provides new therapy to patients facing this difficult-to-treat cancer," said Chirfi Guindo, Managing Director, Merck Canada Inc. "This new product embodies Merck's unwavering commitment to be at the forefront of scientific discovery and innovation to help Canadian patients. . . ."

Smallish good news, there -- but good, nonetheless. Onward.

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