Drug Approval | November 21, 2025
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
Long-term OGSIVEO treatment for up to four years associated with further tumor reductions, increased objective response rate, sustained symptom improvement, and consistent safety profile
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone
DSP-5336, an Investigational Menin and Mixed-lineage Leukemia Inhibitor, is Being Evaluated in Patients with Relapsed or Refractory Acute Leukemia
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
First and only BTK inhibitor to demonstrate favourable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting
First BTK inhibitor to show favourable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting
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