Merck's Keytruda ready for quick FDA action on big melanoma expansion

Merck & Co.'s ($MRK) Keytruda has jumped on the FDA's priority review track for a new first-line use in melanoma. The PD-1 immunotherapy, already approved to treat relapsed melanoma and under FDA review in lung cancer, needs the broader melanoma approval to keep abreast of Bristol-Myers Squibb's ($BMY) rival drug Opdivo.

In fact, thanks to a delay on Opdivo's first-line melanoma use, announced by the company last week, Merck might gain access to that market only a few weeks after Bristol-Myers does. That would keep the immuno-oncology race in melanoma almost neck-and-neck.

Keytruda managed to squeak past Opdivo for a first-in-class FDA approval last fall, and quickly grabbed the sales lead, with $83 million in first-quarter revenue compared with Opdivo's $40 million. Bristol-Myers won a quick nod in lung cancer, however, putting Opdivo ahead in that disease by several months; Keytruda is waiting for the FDA's news on that use. By the second quarter, Opdivo sales had edged ahead. The Bristol-Myers drug nabbed $122 million for the period compared with Keytruda's $110 million.

Bristol-Myers had been expected to sail far ahead of its immuno-oncology rivals, but obviously, Merck has other ideas. Analysts have said Merck's initial lung cancer approval might cover a bigger population than Bristol-Myers', giving Keytruda a shot at a market share coup. Couple that with a quick first-line melanoma nod, and Merck's prospects look promising. New data showing Keytruda beating Bristol-Myers' Yervoy in melanoma might help even more.

But Bristol-Myers has its own new data to tout: Its Opdivo-plus-Yervoy combo delivered a complete response in 22% of patients in one melanoma trial, and Opdivo trounced Novartis' ($NVS) Afinitor in a kidney cancer trial, opening up another potential indication.

Meanwhile, Roche ($RHHBY) is coming on fast with its PD-L1 drug. Just last week, the Swiss drugmaker unveiled new non-small cell lung cancer data from a big midstage study. That drug, atezolizumab, has the FDA's breakthrough designation and could hustle onto the market.

The FDA is due to decide on the first-line Keytruda use in melanoma by Dec. 19, while Opdivo's decision date is now Nov. 27. Bristol-Myers had originally expected an answer later this month, but the company submitted additional data, giving the FDA more info to sift through before making a decision.

- read the Merck release

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