The U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
Simponi Aria Approved by U.S. FDA for Active Polyarticular Juvenile Idiopathic Arthritis
Active Polyarticular Juvenile Idiopathic Arthritis (pJIA), Active Psoriatic Arthritis (PsA), Approvals, Blockbusters, Expanded Indication, FDA, FDA/Regulatory, IV Infusion, New Indications, Therapeutics, Tumor Necrosis Factor (TNF)The U.S. Food and Drug Administration approved Janssen’s Simponi Aria (golimumab) for patients 2 years of age and older for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) and extended the medicine’s active psoriatic arthritis (PsA) indication for this same patient population.
The U.S. Food and Drug Administration approved a supplemental New Drug Application for Shionogi & Co. Ltd.’s Fetroja (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Immunomedics drug Trodelvy extends survival in breast cancer patients
Accelerated Approval, Antibody-Drug Conjugates (ADCs), Boxed Warning, Business, Cancer Cells, Clinical Trials, Deals, European Society for Medical Oncology (ESMO), FDA, Metastatic Triple-Negative Breast Cancer (mTNBC), R&D, TherapeuticsImmunomedics Inc.’s cancer drug Trodelvy, which received accelerated U.S. regulatory approval in April 2020, extended survival time in previously treated patients with an advanced form of breast cancer in a clinical trial.
The U.S. Food and Drug Administration granted accelerated approval for NS Pharma’s Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.
The U.S. Food and Drug Administration approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.
The U.S. Food and Drug Administration granted accelerated approval to Gilead Company Kite’s Tecartus (brexucabtagene autoleucel, formerly KTE-X19) as the first approved chimeric antigen receptor T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals and company partner PharmaMar’s Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.
U.S. FDA Approves Rubraca as Monotherapy Treatment for mCRPC
Accelerated Approval, Acute Myeloid Leukemia (AML), Androgen Receptor-Directed Therapy, Approvals, BRCA Mutation-Associated Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemotherapy, FDA, FDA/Regulatory, Myelodysplastic Syndromes, New Indications, PARP Inhibitors, Supplemental New Drug Application (sNDA), Taxane-Based ChemotherapyThe U.S. Food and Drug Administration approved Clovis Oncology Inc.’s Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
FDA Approves Eli Lilly’s Precision Oncology Treatment for Certain Lung and Thyroid Cancers
Accelerated Approval, Approvals, FDA, FDA/Regulatory, Metastatic Rearranged During Transfection (RET) Fusion-Positive Non-Small Cell Lung Cancer (NSCLC), New Drug Approvals, Precision Oncology, Product Launches, RET Kinase Inhibitors, Safety Warnings, Specialty Pharmacies, TumorsEli Lilly is moving quickly to get the newly approved precision oncology treatment Retevmo for certain lung and thyroid cancers into the hands of patients.