Why the FDA Extended Review Date on Key Melanoma Drug Opdivo

The company issued a press release after the close on Wednesday that the FDA has now extended the action date for the supplemental biologics license application for Opdivo in the war against advanced melanoma. While this may not ultimately prove to be bad in the long term, the reality is that this is one of the big drug candidates that was looking for an expanded use.

Bristol-Myers Squibb said that it has taken the opportunity to submit additional data from the Opdivo clinical trial program — to ensure the broadest data set, irrespective of BRAF status, was available for review.

The company said that this submission constitutes a major amendment that will require additional time for review and the new FDA action date is November 27, 2015. To put this in context, analysts expect annual Opdivo sales to peak at or above $5 billion per year if it can reach expanded approvals. Bristol-Myers Squibb said:

The sBLA was accepted by the FDA for filing and received priority review designation on April 29, 2015, and included data from the Phase 3 CheckMate -066 trial which evaluated Opdivo in treatment naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy (DTIC). The company will continue to work closely with the agency to support the review of this sBLA for Opdivo.

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Opdivo has already received approval from the FDA as a monotherapy in two cancer indications:

• In March of this year, Opdivo received FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
• In the United States, Opdivo is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

Also, there are many more potential targets here with Opdivo. Bristol-Myers Squibb said that it has a global development program to study Opdivo in multiple tumor types consisting of more than 50 trials. These would be as monotherapy treatments (standalone) or in combination with other therapies. It has said that over 8,000 patients have been enrolled worldwide.

Bristol-Myers Squibb shares closed down 0.4% at $62.39, with a $70.78 consensus price target from analysts and a 52-week range of $47.55 to $70.54.

Bristol-Myers Squibb had $15.9 billion in 2014 total revenues. Thomson Reuters has the consensus estimates of $16.0 billion in total company revenues in 2015 and almost $16.8 billion for 2016. Bristol-Myers Squibb has a market capitalization of $104 billion.

Blockbuster drugs, particularly new approvals or expanded uses, can add up to serious revenue growth for biopharma stocks, which are all facing patent cliffs ahead or had to face patent cliffs in recent years.

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