Category: Oncology

News Biologics Oncology Regulatory Approval

U.S. FDA Approves Merck’s Keytruda Qlex, a Faster-Administered Subcutaneous Version of Keytruda for Cancer Treatment

Merck MSD

The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda Qlex, a new subcutaneous formulation of its leading cancer immunotherapy drug. This game-changing approval introduces a fixed-dose combination of pembrolizumab and berahyaluronidase alfa-pmph, allowing the treatment to be administered as a simple injection in as little as one minute, a significant reduction from the previous 30-minute intravenous infusion. Approved for most of Keytruda’s existing solid tumor indications in adults, this new formulation was shown in clinical trials to have a comparable efficacy and safety profile to the IV version. The approval marks a major advancement in patient-centered care, offering a more convenient and less time-consuming option for thousands of cancer patients.

Clinical Trials News Oncology

AstraZeneca’s Tagrisso Combination Therapy Sets New Survival Benchmark in Advanced Lung Cancer

AstraZeneca

hase III trial called FLAURA2 has demonstrated that the combination of AstraZeneca’s drug, Tagrisso, with chemotherapy has led to a median overall survival of nearly four years for patients with a specific type of advanced lung cancer. This marks the longest survival benefit ever recorded in a global trial for this condition, solidifying Tagrisso as a standard-of-care treatment and providing a new benchmark for patient outcomes.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

Lilly’s Olomorasib Granted U.S. FDA Breakthrough Therapy Designation for Advanced Lung Cancer

Eli Lilly and Company

Eli Lilly announced its novel cancer drug, olomorasib, has been granted Breakthrough Therapy designation by the U.S. FDA. This significant milestone aims to expedite the development of the treatment for patients with advanced KRAS G12C-mutated non-small cell lung cancer, a historically difficult-to-treat condition.

Clinical Trials News Oncology

AstraZeneca’s Tagrisso with Chemotherapy Shows Significant Survival Benefit in Advanced Lung Cancer

AstraZeneca

AstraZeneca announced groundbreaking results from its FLAURA2 Phase III trial, revealing that Tagrisso (osimertinib) combined with chemotherapy offers a statistically significant and clinically meaningful improvement in overall survival for patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC).

Clinical Trials News Oncology

Pfizer and Astellas Announce Landmark Survival Benefit with XTANDI in Prostate Cancer Trial

pfizer news

Pfizer and Astellas report groundbreaking Phase 3 EMBARK trial results showing XTANDI® (enzalutamide) plus leuprolide significantly improves overall survival in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence. This marks the first time an androgen receptor inhibitor-based therapy has shown a definitive survival benefit in this specific patient population, offering new hope for extending lives through early and effective treatment.