A cloud hangs over the approval of Roche's Tecentriq in the second line treatment of bladder cancer following the failure of a confirmatory Phase III trial. Meanwhile, rival product Bavencio from Merck KGaA and Pfizer has been granted accelerated approval by the FDA.
A Phase III trial ‒ IMVigor211 ‒ in second-line urothelial (bladder) cancer of Roche's anti-PD-L1 immuno-oncology drug Tecentriq (atezolizumab) has failed to show a survival benefit. This study was required to confirm full approval with the US FDA following Tecentriq's accelerated approval last year based on the IMvigor210 study.
"This comes as a surprise to us, considering Merck & Co. Inc.Keytruda (pembrolizumab) showed an OS (overall survival) benefit...
The Swiss pharma company is rebalancing the portfolio, emphasizing best-in-class drugs and moving into new areas like cardiovascular and metabolic disease.
In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
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