FRANKFURT Nov 29 German drugmaker Merck KGaA
and U.S. partner Pfizer have been granted
priority review status in the United States as they seek
approval to fight a rare and aggressive form of skin cancer with
immunotherapy drug avelumab.
The U.S. Food and Drug Administration has accepted the
request for approval and will review the trial data for the drug
against metastatic Merkel cell carcinoma within six months
instead of the usual 10, Merck said on Tuesday.
Avelumab belongs to a new generation of biotech drugs that
stop some tumours from hiding from the immune system, similar to
Merck & Co's Keytruda or Roche's Tecentriq.
The future of Merck KGaA's pharmaceuticals division rests
largely on avelumab, after the business suffered development
setbacks in several other medicines and amid rising competition
for its established brands, such as Rebif against multiple
The FDA has previously granted Merck and Pfizer other
support schemes for the drug, such as breakthrough therapy
(Reporting by Ludwig Burger; Editing by Georgina Prodhan)