Atirmociclib Phase 2Â data released mark a potentially defining moment in the treatment of hormone receptor-positive metastatic breast cancer. Pfizer’s investigational CDK4 inhibitor demonstrated a statistically [Read More…]
Johnson & Johnson announces 89% complete response rate with Erda-iDRS for intermediate-risk non-muscle-invasive bladder cancer. First-in-human trial shows durable 18-month responses with tolerable safety profile.
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.
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.
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.
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.
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.
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
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.
FDA approves a new simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in combination with LAZCLUZE (lazertinib) for first-line treatment of EGFR-mutated advanced non-small cell lung cancer. The approval allows patients to transition to monthly injections as early as Week 5, significantly reducing clinic visits while maintaining consistent efficacy with the previously approved bi-weekly schedule. PALOMA-2 trial data demonstrated high objective response rates and a fivefold reduction in administration-related reactions compared to intravenous delivery.
