|Merck Serono CEO Belén Garijo|
Merck KGaA and Pfizer ($PFE), playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.
The pair's therapy, called avelumab, blocks a protein called PD-L1 to expose cancerous material to the body's natural defenses. Merck KGaA and Pfizer have identified the rare Merkel cell carcinoma (MCC) as a first disease target, and the FDA has backed up their ambitions in the field with its fast-track mark. With the designation, the companies are guaranteed early and frequent communication with agency officials as they move forward in MCC.
Merck KGaA and Pfizer are well behind their rivals in the so-called checkpoint inhibitor field, with a candidate unlikely to win approval until 2017. Merck ($MRK) and Bristol-Myers Squibb ($BMY) are already on the market with antibodies that block the related PD-1 pathway, selling their treatments for both melanoma and lung cancer in the U.S. On their tails is Roche ($RHHBY), which is soon to file its PD-L1-targeting atezolizumab for global approvals. And AstraZeneca ($AZN) is on the same path with its Phase III durvalumab.
Despite trailing the other contenders, Merck KGaA and Pfizer believe avelumab can catch up by targeting cancers not covered by its more advanced competitors, like MCC. Merck KGaA healthcare chief Belén Garijo said over the summer that avelumab could be among the first three immunotherapies approved in ovarian, gastric, bladder and renal cancers.
Pfizer bought into avelumab, formerly MSB0010718C, last year, paying $850 million up front and as much as $2 billion more for the right to collaborate on up to 20 new cancer immunotherapies.
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