As many industry watchers expected, Pfizer's ($PFE) lung cancer drug Xalkori and Takeda Pharmaceuticals' lymphoma treatment Adcetris passed muster with European regulators and is en route to potential approvals. The companies were among several winners of positive recommendations from the EMA's Committee for Medicinal Products for Human Use (CHMP) on Friday, and their nods represent two cases where the FDA has beat its EU counterpart to the punch.
U.S. regulators gave speedy approvals to both Xalkori and Adcetris nearly a year ago, as the agency builds a track record of green-lighting meds that provide early evidence of efficacy for some of the sickest patients. Xalkori, or crizotinib, homes in on the ALK gene to treat a subset of patients with non-small cell lung cancer. And, as Reuters reported, analysts expect the drug to achieve blockbuster status within the next several years as Pfizer wracks up approvals for the treatment and expands its market.
From developer Seattle Genetics ($SGEN), Adcetris last year became the first drug approved for Hodgkin lymphoma since 1977 and the first med sanctioned for combating anaplastic large cell lymphoma. Takeda has rights to market the drug in Europe and the CHMP nod brightens the future of the Japanese drug giant's oncology business, which is built around its Millennium unit in Cambridge, MA, and features the big-seller Velcade.
- see the EMA's release for a list of the CHMP nods
- get more on Pfizer's victory from Reuters