BMS' Opdivo gets an FDA OK for Hodgkin's

Bristol-Myers Squibb’s superdrug, Opdivo, had already won 7 approvals in two years for treating melanoma, lung and kidney cancers. Now it has snagged its eighth, this time for a rare blood cancer.

BMS today said Opdivo has won approval for treating classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.

The New York-based company said the accelerated approval was garnered based on the combined analysis of data from the Phase II CheckMate 205 and the Phase I CheckMate 039 trials. It said to maintain the approval, the FDA may ask for confirmation of the results in later trials.

Based on that combo analysis, the drug elicited an objective response rate of 65%, with 7% of patients seeing a complete response rate and 58% a partial response rate. Among those that did respond, the response lasted a median of 8.7 months, BMS reported today.

One of the patients involved in the study said in a statement that the treatment gave him something he didn’t otherwise have. “As a classical Hodgkin lymphoma patient who has tried multiple therapies, I know firsthand what it’s like to not have a clear next step,” said Matt Kludt, a patient enrolled in one of the clinical trials. “When I started on Opdivo, I was hopeful about the potential for this new treatment. Now, I’m proud to be able to say I was one of several patients who have helped contribute to the approval of a new therapy that may offer other patients like me the possibility of a high response rate.”

The drug, which competes with Merck’s ($MRK) Keytruda, has thrust BMS to the top in the immuno-oncology field and helped set it up for years of solid growth. It was a key driver in Q1 sales, which blasted by analyst predictions and allowed the company to raise its 2016 guidance to double-digit revenue growth and an earnings per share range of $2.50 to $2.60 for the year, up from its earlier prediction of $2.30 to $2.40.

Opdivo generated $704 million in Q1 2016, well beyond the $587 million that had been projected by some analysts. Its U.S. sales were $594 million to squash $489.1 million in expectations, but the company said its growth in other markets has also been stellar as it has won new indications.

Still, the company is having to work to win over some payers who are put off by the cost of the drug. England’s National Institute for Health and Care Excellence last week decided the drug was still too expensive for an approval in lung cancer, despite the fact that it outperformed currently approved treatments, with fewer side effects, in a disease where patients have few options.

BMS even offered a special incentive. If England’s National Health Service would pay for 26 weeks of treatment at a cost of about £31,000 ($45,000), BMS would cover the next 26 weeks if a patient needed another round. No go, NICE said. The guidance is preliminary, and a denial is not unusual as NICE continues to try to extract further discounts from companies. The price watchdog is taking comments through June 3, after which it will issue its final decision.

- here’s the release

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