Exelixis Announces Positive Opinion from European Medicines Agency for Cobimetinib in Treating BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma

Strategic Insights -

The European Medicines Agency's Committee for Medical Products for Human Use (CHMP) has given a positive opinion for the marketing authorization of cobimetinib, a selective MEK inhibitor discovered by Exelixis, in combination with vemurafenib for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. This recommendation is based on data from the coBRIM trial, a randomized, double-blind, controlled phase 3 pivotal trial evaluating cobimetinib in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

Key Takeaways:

  • Exelixis' cobimetinib, a selective MEK inhibitor, has received a positive opinion from the European Medicines Agency's CHMP for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma in combination with vemurafenib.
  • The recommendation is based on data from the coBRIM trial, which evaluated cobimetinib in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation.
  • The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
  • Exelixis expects the European Commission to release its final decision regarding the approval of the combination of cobimetinib and vemurafenib by the end of 2015.
  • The cobimetinib and vemurafenib combination has also received EU approval in Switzerland, where cobimetinib is marketed as Cotellic.
  • Exelixis is eligible to receive royalties on sales of cobimetinib outside the United States, and if approved in the U.S., Exelixis is entitled to an equal share of U.S. profits and losses, which will decrease as sales increase.
  • The coBRIM trial was conducted by Roche and Genentech, a member of the Roche Group, who filed a New Drug Application (NDA) for cobimetinib in the U.S., with a Prescription Drug User Fee Act (PDUFA) action date of November 11, 2015.

Statistics:

  • Approximately 50% of melanomas harbor a BRAF mutation, and the BRAF V600 mutation-positive form of melanoma is associated with high-risk characteristics of the disease.
  • The coBRIM trial evaluated cobimetinib in combination with vemurafenib in 495 patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation.
  • The cobimetinib and vemurafenib combination has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
  • Exelixis has a collaboration agreement with Genentech to co-promote cobimetinib in the U.S., with Exelixis prepared to support up to 25% of the U.S. sales force.

Sources:

  • Exelixis. (2015, September 25). Exelixis Announces Positive Opinion from CHMP for Cobimetinib in Treating BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma [Business Wire].
  • Exelixis. (2015, August 11). Exelixis Reports Second Quarter 2015 Financial Results [Exelixis press release].
  • Exelixis. (2015, May 26). Exelixis, Inc. to Present at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) [Exelixis press release].