FDA Grants Landmark Approval for REVTORPYK: A New Standard for PIK3CA Wild-Type Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Celcuity’s REVTORPYK (gedatolisib) for the treatment of HR+/HER2- metastatic breast cancer patients who do not possess a PIK3CA mutation. As the first therapy capable of inhibiting all class I PI3K isoforms (α, β, δ, γ) in conjunction with both mTORC1 and mTORC2 complexes, REVTORPYK introduces a novel mechanism of action for a patient population that accounts for approximately 42% of all HR+/HER2- diagnoses. Also read:
5 hours ago2 min read
FDA Approval of Sarclisa Escena Marks Shift Toward Subcutaneous Oncology Delivery | iPharmaCenter
The U.S. Food and Drug Administration (FDA) has officially approved the subcutaneous formulation of Sarclisa (isatuximab), branded as Escena, establishing it as the first anticancer therapy to utilize an on-body injector (OBI). Also read: CVS Pharmacy Joins Medicare GLP-1 Bridge and Scales Weight‑Loss Access Across the U.S Powered by the CirCLIQ platform, this new delivery method offers patients the option for either manual subcutaneous administration or automated, hands-free
1 day ago2 min read
FDA Approves KEYTRUDA-Padcev Combo as First Perioperative Standard for Muscle-Invasive Bladder Cancer
The FDA has officially approved a novel perioperative treatment regimen for muscle-invasive bladder cancer (MIBC), authorizing the combination of Merck’s KEYTRUDA—including the new subcutaneous formulation, KEYTRUDA QLEX, with Pfizer and Astellas’ antibody-drug conjugate (ADC), Padcev. This regulatory milestone represents the first instance of a PD-1 inhibitor and ADC combination being approved for MIBC, irrespective of a patient’s eligibility for cisplatin-based chemotherapy
4 days ago2 min read
FDA Clears Sanofi’s Tzield as First Disease-Modifying Therapy for Stage 3 Type 1 Diabetes | iPharmaCenter
Sanofi has secured US regulatory clearance for Tzield as a treatment aimed at modifying disease progression in children recently diagnosed with stage 3 type 1 diabetes. The authorization marks the first time a therapy has been approved in this setting to help preserve the body’s own insulin production. The US Food and Drug Administration granted accelerated approval for Tzield for use in patients aged 8 to 17 years who have been newly diagnosed with stage 3 type 1 diabetes.
Jun 172 min read
FDA Approves Datroway as First TROP2-Directed ADC for First-Line Metastatic Triple-Negative Breast Cancer in Non-PD-1/PD-L1 Candidates
The US Food and Drug Administration has approved Datroway, developed by AstraZeneca and Daiichi Sankyo, as the first TROP2-directed antibody drug conjugate cleared for first-line treatment of metastatic triple-negative breast cancer in patients who are not suitable candidates for PD-1 or PD-L1 inhibitor therapy. This approval marks a significant shift in how this difficult-to-treat cancer may be managed going forward. What is Datroway and Why Does This Approval Matter? Datr
May 222 min read