Category: Oncology

News Clinical Data Oncology Regulatory

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.

Clinical Trials News 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.

Regulatory Approval News Oncology

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.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

Johnson & Johnson Announces FDA Approval of TECVAYLI® Plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma

JohnsonAndJohnson

Johnson & Johnson announced FDA approval of TECVAYLI plus DARZALEX FASPRO for relapsed/refractory multiple myeloma with unprecedented clinical data demonstrating significant improvements in progression-free survival and overall survival.

Regulatory Approval News Oncology

PADCEV and Keytruda FDA Approval: Breakthrough Perioperative Treatment Cuts Bladder Cancer Death Risk by 50%

pfizer news

The FDA has approved PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as the first perioperative treatment regimen to significantly improve survival in cisplatin-ineligible patients with muscle-invasive bladder cancer. Based on pivotal Phase 3 EV-303 trial data, the combination demonstrated a 60% reduction in recurrence or death risk and a 50% reduction in mortality risk compared to surgery alone.

Regulatory Approval News Oncology

Pfizer’s BRAFTOVI Receives FDA Full Approval for First-Line Metastatic Colorectal Cancer Treatment

pfizer news

Pfizer announced FDA full approval of BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for treating adults with BRAF V600E-mutant metastatic colorectal cancer. The landmark approval is backed by Phase 3 BREAKWATER trial data demonstrating a 51% reduction in mortality risk and 47% reduction in disease progression risk compared to standard chemotherapy.

Regulatory Approval News Oncology

U.S. FDA Approves Venclexta and Acalabrutinib Combination for First-Line CLL Treatment

AbbVie

On February 20, 2026, the U.S. FDA approved the combination of Venclexta (venetoclax) and acalabrutinib for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This landmark decision establishes the first and only all-oral, fixed-duration (time-limited) regimen for previously untreated patients, offering a significant alternative to continuous therapy or chemoimmunotherapy

Clinical Trials News Oncology

Pfizer’s BRAFTOVI Regimen Demonstrates Significant Progression-Free Survival Benefit in Advanced Colorectal Cancer

pfizer news

Pfizer announced positive progression-free survival results from BREAKWATER trial Cohort 3, showing BRAFTOVI combined with cetuximab and FOLFIRI achieves statistically significant and clinically meaningful progression-free survival improvement compared to chemotherapy alone in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.