Update: Merck KGaA, Pfizer score landmark FDA nod for checkpoint contender Avelumab

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This is an update to my story: “German Merck, flying under Street’s radar, gets no respect; but not for long

Germany’s Merck KGaA and part­ner Pfizer Inc. came away with their first FDA ap­proval of the check­point in­hibitor avelumab, mak­ing it the fourth drug in this cat­e­gory to make it to the mar­ket. They beat out As­traZeneca PLC, which will now angle for its first ap­proval of durvalumab as the 5th check­point.

@MerckGroup, @Pfizer get their first @us_fda ap­proval of the check­point in­hibitor #avelumab Click To Tweet

The FDA gave out its ap­proval for Merkel cell car­ci­noma under an ac­cel­er­ated ap­proval process. The ther­apy, the first for a rare form of skin can­cer, has also been given break­through drug sta­tus. The drug is cur­rently in 30 clin­i­cal pro­grams as the two play­ers look to wedge their way into a multi­bil­lion-dol­lar mar­ket for drugs that are gain­ing wide use in treat­ing can­cer.

The ap­proval marks an­other big ad­vance for Pfizer, which paid $850 mil­lion up­front to part­ner with Ger­many’s Merck–a record sum. The ap­proval of this anti-PD-L1 IgG1 mon­o­clonal an­ti­body also marks a major win for Merck KGaA, which has suf­fered through more than a decade with­out a block­buster. Merck KGaA also came away with a pack­age of reg­u­la­tory and com­mer­cial mile­stones on avelumab worth up to $2 bil­lion when it tied up with Pfizer in 2014.

The ther­apy will be sold as Baven­cio (pdf). A spokesper­son for Pfizer said the drug will cost $13,000 a month whole­sale–before payer dis­counts. (Source: Endpoints News)

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