Seattle Genetics said the FDA has granted accelerated approval for Padcev, or enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic setting.
Early Approval A Positive
The approval, which was granted based on tumor response rate, came just three months after the filing of the sBLA and well ahead of the March 2020 PDUFA date. The FDA grants accelerated approval based on a surrogate endpoint, if a therapy fills an unmet need for a serious condition.
Continued approval, according to the company, is contingent on verification and description of clinical benefit in confirmatory trials.
Padcev is directed against Nectin-4, a protein highly expressed in bladder cancer.
"Metastatic urothelial cancer is an aggressive and devastating disease with limited treatment options, and the approval of PADCEV is a significant advance for these patients who previously had limited options after initial therapies failed," said Jonathan Rosenberg, a clinical oncologist.
Seattle Genetics said a global randomized Phase 3 trial dubbed EV-301 is currently underway, which would also support regulatory filings outside of the U.S.
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Analyst Sees Measured Launch
The early approval is a positive for Seattle, offering an avenue to diversify into solid tumors, Bank of America analyst Geoff Meacham said. Despite the early approval, the three additional months on the market is unlikely to change the near-take uptake trajectory.
The analyst expects a measured launch, with estimated revenues of $56 million for 2020 compared to the $32-million consensus estimate.
Meacham expects pricing to come at the low end of the expected $110,000-$12,000, which could drive faster adoption and create goodwill among providers.
"While we acknowledge the momentum of the business as a whole, in our view it is well appreciated by the market at current levels as reflected in the stock returns this year," Meacham wrote in a note.
The firm reiterated its Neutral rating on Seattle Genetics, with a $125 price target.
Seattle Genetics shares traded higher by 4.2% to $117.56.