Novartis has announced updated analysis from its Phase III NATALEE trial showing that Kisqali (ribociclib) continues to demonstrate sustained reduction in distant recurrence when combined with endocrine therapy. The treatment showed a 28.5% reduction in distant recurrence compared to endocrine therapy alone in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer. “In day-to-day…
Merck has announced that its Phase 3 KEYLYNK-001 trial met its primary endpoint of progression-free survival (PFS) in patients with advanced epithelial ovarian cancer. The study evaluated KEYTRUDA plus chemotherapy followed by maintenance with LYNPARZA, with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer. “For people living with ovarian cancer, there remains an unmet…
AbbVie has received European Commission (EC) marketing authorization for ELAHERE (mirvetuximab soravtansine) for the treatment of platinum-resistant ovarian cancer. The approval marks the first folate receptor alpha (FRɑ)-directed antibody drug conjugate approved in the European Union, Iceland, Liechtenstein, Norway, and Northern Ireland. The treatment specifically targets adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or…
AbbVie has announced the acquisition of Aliada Therapeutics for $1.4 billion in cash, strengthening its position in neuroscience drug development. The deal centers on Aliada’s novel blood-brain barrier (BBB)-crossing technology and its lead Alzheimer’s disease candidate, ALIA-1758, a development particularly significant given that women represent nearly two-thirds of Americans living with Alzheimer’s disease. Aliada’s proprietary MODEL platform enables high-precision central nervous system…
Organon has announced the completion of its acquisition of Dermavant Sciences from Roivant, a deal first reported in September 2024. The completion comes at a strategic time, as the FDA reviews VTAMA cream’s potential expansion into atopic dermatitis treatment, with a decision expected in Q4 2024. VTAMA (tapinarof) cream, 1%, Dermavant’s flagship product, represents a unique addition to Organon’s portfolio as a…
The U.S. Food and Drug Administration (FDA) has approved Genentech’s Itovebi (inavolisib) for the treatment of advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with a PIK3CA mutation. Itovebi is to be used in combination with palbociclib (Ibrance) and fulvestrant. This approval is based on results from the Phase III INAVO120 study, which showed that the Itovebi-based…
Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Kisqali (ribociclib) for a new indication in early breast cancer. This approval marks a significant development in breast cancer treatment, particularly for women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer. The FDA has approved Kisqali in combination with an aromatase inhibitor for adjuvant…
Organon has announced its plans to acquire Dermavant Sciences, a Roivant company focused on innovative immuno-dermatology treatments. The deal, which is expected to be finalized in the fourth quarter of 2024, will allow Organon to expand its dermatology offerings in the U.S. market, particularly with Dermavant’s flagship product, VTAMA (tapinarof) cream, 1%. VTAMA cream, a novel, non-steroidal topical therapy, was approved by…
