GSK Secures Japan Orphan Drug Designation for Risvutatug Rezetecan in Small-Cell Lung Cancer

GSK - GlaxoSmithKline

GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data from the ARTEMIS-001 trial, this B7-H3-targeted antibody-drug conjugate aims to transform the prognosis for patients with extensive-stage disease, who currently face a median survival of just 8 months. This marks the sixth major global regulatory designation for risvutatug rezetecan, signaling its critical role in the future of oncology.

Roche Announces Topline Phase 3 Results and FDA Acceptance of Giredestrant for Breast Cancer Treatment

Roche

While Roche’s persevERA trial didn’t meet its primary endpoint, the pharmaceutical company remains committed to advancing giredestrant as a new standard-of-care endocrine therapy. The FDA has accepted the company’s New Drug Application based on positive evERA data, signaling promise for this ER-positive breast cancer treatment.

European Commission Grants Approval for AKEEGA®: A New Precision Medicine Milestone for BRCA-Mutated Metastatic Prostate Cancer

JohnsonAndJohnson

Johnson & Johnson secures EC approval for AKEEGA® as the first precision-medicine combo for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer, supported by landmark rPFS data from the AMPLITUDE trial.