Tag Archive for: Oncology

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.

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.

Staff reviewers said that the pattern of early deaths observed in patients treated with both the therapies in their respective trials raised uncertainty about the treatments’ overall survival benefit in patients.

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.

The company stated that Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen.

Bristol Myers Squibb’s Opdivo was recently granted FDA approval in combination with cisplatin and gemcitabine as a first-line treatment for metastatic urothelial carcinoma. With this approval, Opdivo positions itself to compete with Merck & Co’s immune checkpoint inhibitor Keytruda in combination with Astellas and Pfizer’s Padcev, a nectin-4-directed antibody-drug conjugate, according to GlobalData.

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.