New late-stage trial results for GSK’s Jemperli show improved overall and progression-free survival in a broader range of endometrial cancer patients, which could lead to a potential label expansion.
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Yesterday’s approval comes months after Novartis turned its back on tislelizumab, returning global rights to BeiGene. The companies signed a collaboration contract for tislelizumab in January 2021, but ran into several regulatory roadblocks.
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
A company executive stated that Gilead will be able to quadruple production of its cell therapy cancer treatments by 2026 due to improvements in the U.S. biotech’s manufacturing processes.
The collaboration will include the development of computational pathology algorithms powered by AI and machine learning (ML) that connect baseline pathology data, such as molecular tumor profiles, with clinical data, such as patient outcomes, to enable better patient identification, stratification, and selection for clinical trials.
Merck & Co said it plans to conduct clinical trials testing its human papillomavirus (HPV) vaccine Gardasil 9 to evaluate the efficacy and safety of a single-dose regimen compared to the approved three-dose regimen.
Yesterday the agency ranted accelerated approval to BeiGene’s BTK inhibitor Brukinsa (zanubrutinib), when used in combination with Genentech’s Gazyva (obinutuzumab), to treat patients with relapsed or refractory follicular lymphoma who have undergone at least two lines of systemic therapy.
The early-stage oncology startup filed for an initial public offering on Wednesday, seeking funds to help develop its novel cancer therapies targeting extrachromosomal DNA.
Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.
The financing was secured from life sciences investment company Abingworth and will help Gilead run “select clinical studies” of Trodelvy.