More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin).
Stealth Biotherapeutics Inc., and, more importantly, patients with Barth syndrome, faced another disappointing delay April 29 when the U.S. FDA kicked its approval decision down the road for Stealth’s elamipretide.
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
Venatorx Pharmaceuticals Inc. on Aug. 15 said the U.S. FDA accepted its NDA for an intravenous antibiotic combination, cefepime-taniborbactam, to treat complicated urinary tract infection (cUTI), including acute pyelonephritis.
The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. The PDUFA VII letter, which is to be presented to Congress by Jan. 15, is no exception.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
Athenex Inc.’s launch of Klisyri (tirbanibulin) likely whetted investor appetite for another prospect coming down the pike: Oraxol, an oral form of paclitaxel for which the Buffalo, N.Y.-based firm has been assigned a PDUFA date of Feb. 28.
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