Merck & Co. has stealthily filed its highly anticipated Keytruda plus chemotherapy combination for first-line treatment of non-small cell lung cancer on the back of Phase II data, months earlier than expected and before the completion of a Phase III study.
The countdown to May 10 – the much earlier than expected FDA assessment date for Merck's Keytruda (pembrolizumab) plus chemotherapy treatment for first-line use in lung cancer – has begun, and the anticipated regulatory nod in this patient population has analysts editing their forecasts for the entire non-small cell lung cancer market.
On Jan. 10, the US FDA accepted Merck & Co. Inc.'s supplemental biologics license application for Keytruda in combination...
The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.
Attendees at this year's European Society for Medical Oncology meeting in Barcelona can look forward to a range of interesting datasets, from Phase III trials of established products in new settings to preliminary studies of novel products coming through the pipeline.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
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.
Ordspono, a bispecific antibody newly approved in the EU to treat follicular lymphoma and diffuse large B-cell lymphoma, joins Libtayo in Regeneron’s growing oncology portfolio.
