The PD-L1 inhibitor's label excludes NSCLC patients with EGFR or ALK mutations, which could have been an advantage, but the indication largely reflects the registrational IMpower150 clinical trial's population.
At long last, Roche's anti-PD-L1 Tecentriq was approved on Dec. 6 by the US FDA for use with the company's VEGF inhibitor Avastin and chemotherapy for first-line, metastatic non-squamous, non-small cell lung cancer (NSCLC), though patients with EGFR and ALK mutations were excluded, eliminating an expected labeling advantage.
Approval was supported by the results of the Phase III IMpower150 study, one of eight trials that are part of...
The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
As clinical trials grow more complex, execution pressures are changing where and how evidence is collected.
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.
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.
