FDA expands Opdivo’s melanoma approval to include BRAF-mutant patients

FDA expands Opdivo’s melanoma approval to include BRAF-mutant patients

The US Food and Drug Administration (FDA) has once again expanded the indications for Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) cancer drug.

The company is now allowed to use Opdivo in combination with Yervoy (ipilimumab) to treat unresectable or metastatic melanoma across BRAF mutational status.

The indication includes both BRAF-wild type and BRAF-mutant melanoma. The agency has also expanded the indication for single-agent Opdivo to include patients with previously untreated BRAF mutation-positive advanced melanoma patients.

In the CheckMate-067 study, the combination of Opdivo and Yervoy reduced the risk of progression by 58% compared with Yervoy alone in patients with advanced melanoma.

Single-agent Opdivo reduced the risk of progression by 43% versus Yervoy.

The approvals increase the number of Opdivo indications to seven, including four in melanoma, all granted since late 2014.

BMS head of US commercial Chris Boerner said: “CheckMate -067 is the first Phase 3 study to observe the efficacy and safety of both Opdivo as a single-agent as well as in combination with Yervoy versus Yervoy alone.

“To make this treatment option available to more patients is truly a milestone in the fight against this deadly disease.”

Last November, the FDA accepted for filing and priority review a supplemental biologics license application for Opdivo to treat patients with advanced renal cell carcinoma, who have received prior anti-angiogenic therapy.

The projected FDA action date is 16 March 2016.

Opdivo is also is also being assessed in combination with Seattle Genetics’ Adcetris (brentuximab vedotin) antibody-drug conjugate.

Published 25 January 2016

http://regulatoryaffairs.pharmaceutical-business-review.com/

January 25, 2016 / Pharma News