Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer.

After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet April 30 to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR+HER2- locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic hormone-sensitive prostate cancer that’s phosphatase and tensin homolog deficient.

CDKs are central regulators of cell-cycle progression in cancer, with resistance to CDK4/6 inhibitors frequently converging on CDK2 activation through cyclin E upregulation or CCNE1 amplification, supporting CDK2 inhibition as a strategy to restore cell-cycle control. Researchers from Novartis AG have revealed the preclinical profile of ECI-830, an oral bioavailable, highly selective ATP-competitive CDK2 inhibitor.

A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.

Researchers from Sanofi SA have detailed the development of a next-generation HER2-targeting T-cell engager (TCE) to increase selectivity for HER2-low tumor cells, while minimizing its effects on normal tissues expressing physiologic levels of HER2.

A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.

The discovery and development of new histone lysine acetyltransferase KAT6 inhibitors is a significant advancement in the management of breast cancer. Investigators from Olema Pharmaceuticals Inc. and Aurigene Oncology Ltd. recently presented data for their KAT6 inhibitor, OP-3136, as an approach for breast cancer.

In a recent study published in the Journal of Cancer Research and Clinical Oncology, researchers from The First Affiliated Hospital of Guangxi Medical University and The First People’s Hospital of Qinzhou (China) investigated the expression pattern, molecular mechanisms and clinical relevance of GALNT1 in breast cancer.