Bristol-Myers gets U.K. boost for blockbuster contender Opdivo, weeks after FDA approval

Bristol-Myers Squibb ($BMY) just snagged U.S. approval for its new PD-1 cancer immunotherapy Opdivo, but already is building some momentum for the drug it expects to lead its growth this year. Just two weeks after the FDA gave the melanoma drug an early approval, the U.K.s Medicines and Healthcare products Regulatory Agency (MHRA), has tagged it with designation that could lead to early approval there.

MHRA named it a Promising Innovative Medicine (PIM), the first-step in a process similar to the FDA's "breakthrough" status, PMLive reports. If approved under the the U.K.'s Early Access to Medicines Scheme, it would allow doctors to use the med before its license is approved. The program was launched early last year and Opdivo is only the second med given the PIM status.

PD-1 inhibitors, which block a mechanism cancer cells use to escape detection by the body's immune system, are a new generation of cancer treatment that are expected to bring in multiple billions of dollars. Opdivo and Merck's ($MRK) Keytruda, which was approved in September, are the first two drugs approved in the class, but other drugmakers are hot in pursuit. AstraZeneca ($AZN) and Roche ($RHHBY) are both working on therapies in this arena.

Johanna Mercier

While the U.K.s early access program allows drugmakers to get meds to patients before official approval, it also requires them to foot the bill until the license is granted, and that was not well received by drugmakers. But Johanna Mercier, BMS general manager in the U.K. and Ireland, said today, "We are … delighted that nivolumab has become one of the first medicines to be awarded a PIM designation," as quoted by PMLive. "We will now work closely with the NHS to ensure all those eligible are able to benefit from this breakthrough treatment as soon as possible."

It is the second show of support in England for a BMS targeted melanoma cancer treatment in recent months. Last summer, National Institute for Health and Care Excellence (NICE) did a turn-about and recommended BMS' Yervoy as a first-line treatment for melanoma. NICE was widely criticized after initially showing little support for a drug doctors and patient groups wanted available there. Yervoy has been a hot seller for BMS. The drugmaker saw sales of Yervoy grow 47% to $350 million in the third quarter.

BMS has very large expectations for Opdivo as well. It has the drug in a host of clinical trials in combination with other meds that could lead it to approval for treating a host of cancers, boosting its blockbuster potential further. After reporting success with Opdivo in non-small cell lung cancer, Leerink's Seamus Fernandez upped his 2020 sales projections for the drug to $7.3 billion from $4.8 billion and said he expected it to lead the category.

- read the PMLive story

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