FRIDAY, March 20, 2020 -- Epclusa (sofosbuvir and velpatasvir) received approval for a supplemental application to treat hepatitis C virus (HCV) in children without cirrhosis or with mild cirrhosis, the U.S. Food and Drug Administration announced Thursday.
The supplemental application of Epclusa is indicated for children ages 6 years and older or weighing at least 37 lb who have HCV genotypes 1, 2, 3, 4, or 6. Epclusa combined with ribavirin is indicated for treating children 6 years and older or at least 37 lb with severe cirrhosis, and the FDA previously approved the drug to treat HCV in adults.
TUESDAY, March 10, 2020 -- Ofev (nintedanib) oral capsules have received the first approval for the treatment of patients with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, the U.S. Food and Drug Administration announced Monday.
Ofev, a multitargeted tyrosine kinase inhibitor, was approved in 2014 to treat idiopathic pulmonary fibrosis and to slow pulmonary function decline among patients with ILD associated with systemic sclerosis or scleroderma.
MONDAY, March 9, 2020 -- Isturisa (osilodrostat) oral tablets have been approved to treat adults with Cushing disease, the U.S. Food and Drug Administration announced Friday.
Isturisa is indicated in adults with Cushing disease who are not candidates for pituitary gland surgery or who have had the surgery but still have the disease. The drug works by blocking the enzyme 11-beta-hydroxylase and preventing cortisol synthesis. Isturisa is taken orally twice a day, in the morning and evening. After treatment initiation, health care providers may reevaluate dosage based on the patient's response.
TUESDAY, March 3, 2020 -- Sarclisa (isatuximab-irfc) has been approved for the treatment of adults with multiple myeloma in combination with pomalidomide and dexamethasone, the U.S. Food and Drug Administration announced Monday.
Sarclisa, in combination with pomalidomide and dexamethasone, is indicated for patients who have previously received two therapies, including lenalidomide and a proteasome inhibitor. Sarclisa, a CD38-directed cytolytic antibody, is administered through intravenous infusion and helps certain cells in the immune system attack multiple myeloma cancer cells.
WEDNESDAY, Feb. 19, 2020 -- The U.S. Food and Drug Administration approved three drugs for nonprescription, over-the-counter use -- Voltaren Arthritis Pain (diclofenac sodium topical gel, 1 percent), Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1 percent), and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2 percent) -- the agency announced Friday.
All three products will now be marketed as nonprescription drugs and will no longer be available as prescription drugs. For the drugs to switch to nonprescription status, data had to demonstrate the drugs' safety and efficacy for self-medication use as directed in proposed labeling, according to the FDA.
MONDAY, Feb. 3, 2020 -- The U.S. Food and Drug Administration approved Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) to alleviate allergic reactions to accidental peanut exposure, the agency announced late Friday.
Palforzia, a powder manufactured from peanuts, is indicated for initiation in individuals aged 4 to 17 years old with a confirmed peanut allergy. Treatment may be continued in individuals aged 4 years and older. "When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy," Peter Marks, M.D., Ph.D., director of the FDA Center for Biologics Evaluation and Research, said in an agency news release.
FRIDAY, Jan. 24, 2020 -- Tazverik (tazemetostat) has received the first approval for treatment of adults and pediatric patients 16 years and older with metastatic or locally advanced epithelioid sarcoma that cannot be resected, the U.S. Food and Drug Administration announced Friday.
The drug works by blocking activity of the EZH2 methyltransferase to help keep the cancer cells from growing. Last month, the Oncologic Drugs Advisory Committee voted unanimously that the benefits of Tazverik outweigh the risks for patients with epithelioid sarcoma, which accounts for less than 1 percent of all soft tissue sarcomas, Richard Pazdur, M.D., director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research, said in an agency news release.
FRIDAY, Jan. 10, 2020 -- The kinase inhibitor Ayvakit (avapritinib) has been approved to treat adults with unresectable or metastatic gastrointestinal stromal tumors (GISTs) with a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, the U.S. Food and Drug Administration announced Thursday.
The approval includes GISTs harboring a PDGFRA D842V mutation, the most common exon 18 mutation, and marks the first time a drug is specifically approved for GISTs harboring the PDGFRA exon 18 mutation, which is involved in about 10 percent of GIST cases.
MONDAY, Dec. 23, 2019 -- Enhertu (fam-trastuzumab deruxtecan-nxki) has received accelerated approval for treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the U.S. Food and Drug Administration announced Friday.
Enhertu, a HER2-directed antibody and topoisomerase inhibitor conjugate, is indicated for adults with unresectable or metastatic HER2-positive breast cancer who have received at least two previous anti-HER2-based regimens in the metastatic setting. The recommended dosage of Enhertu is an intravenous infusion of 5.4 mg/kg once every three weeks (21-day cycle) until disease progression or unacceptable toxicity.
THURSDAY, Dec. 19, 2019 -- Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval for the treatment of locally advanced or metastatic urothelial cancer, the U.S. Food and Drug Administration announced yesterday.
Padcev is indicated for adults whose disease has progressed while receiving standard treatment with a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-based therapy.