April 3 Quick Takes: Padcev label expanded to first-line urothelial cancer
Plus: Ascendis’ market cap melts as thyroid program hits FDA snag and updates from Apellis, Vedere and Vertex-CRISPR
FDA granted accelerated approval to Padcev enfortumab vedotin-ejfv, a nectin-4 antibody-drug conjugate from Seagen Inc. (NASDAQ:SGEN) and Astellas Pharma Inc. (Tokyo:4503), plus Keytruda pembrolizumab to treat locally advanced or metastatic urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy. A move into the first-line setting will expand the market for the drug, with about half of newly diagnosed urothelial cancer patients ineligible for cisplatin due to age or co-morbidities. According to Astellas, an additional 8,000 to 9,000 patients in the U.S. have this form of urothelial cancer and are not eligible for cisplatin-containing chemotherapy. The drug is one of the therapies that attracted Pfizer Inc. (NYSE:PFE), which is acquiring the ADC maker for $43 billion.
Ascendis Pharma A/S (NASDAQ:ASND) shed more than $2 billion in market cap Monday after it said FDA had identified “deficiencies” in its NDA for TransCon PTH palopegteriparatide that preclude discussion about labeling and postmarketing requirements. The company had been expecting an FDA decision by April 30 on the application seeking TransCon PTH’s approval to treat hypoparathyroidism; its shares slipped $34.39 (32%) to $72.83 as investors interpreted the news as a threat to its approval...