RE:Pelareorep in 3rd line HR+/HER2 negative breast cancerOctober 11, 2024 - Roche's drug, inavolisib, has gained FDA approval as part of a first-line treatment for HR-positive, HER2-negative breast cancer that has a PIK3CA mutation and is resistant to adjuvant endocrine therapy. The oral med is to be used in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex.
Itovebi is part of a bigger pipeline that Roche hopes could rejuvenate its breast cancer business. The company’s once flagship HER2 franchise lost some of its luster after Herceptin fell off the patent cliff and Kadcyla comes under pressure from AZ and Daiichi Sankyo’s star antibody-drug conjugate Enhertu.
Besides Itovebi, Roche is advancing the oral SERD drug giredestrant in HR+/HER2- breast cancer, with key phase 3 readouts expected in 2025.
Last week, Roche announced a $850 million upfront deal with Regor Pharmaceuticals, adding an early-stage CDK4/2 inhibitor and a phase 1-ready CDK4 drug to its portfolio.
https://www.fiercepharma.com/pharma/roche-burnishes-breast-cancer-portfolio-fda-approval-itovebi-threat-novartis-and-az