SUNDAY, June 14, 2020 -- Uplizna (inebilizumab-cdon) injection is now approved to treat neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody positive, the U.S. Food and Drug Administration announced Thursday.
Uplizna, approved for intravenous use, is the second treatment for NMOSD approved within the past year. There are an estimated 4,000 to 8,000 patients with NMOSD in the United States, the agency noted.
MONDAY, June 1, 2020 -- Tauvid (flortaucipir F18), a radioactive diagnostic agent, was approved to image tau pathology in patients with cognitive impairment being evaluated for Alzheimer disease, the U.S. Food and Drug Administration announced Thursday.
The drug is indicated for positron emission tomography (PET) imaging to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs). Tauvid is delivered via intravenous injection and binds to brain sites associated with the tau protein, which can be identified through PET scan imaging.
WEDNESDAY, May 27, 2020 -- VESIcare LS (solifenacin succinate) oral suspension is now approved to treat neurogenic detrusor overactivity (NDO) in children 2 years and older, the U.S. Food and Drug Administration announced Tuesday.
VESIcare (solifenacin succinate) tablets were approved in 2004 to treat overactive bladder in patients 18 years and older. VESIcare LS is the first FDA-approved treatment for NDO in patients as young as 2 years and requires only once-daily dosing as opposed to the current standard treatment, which requires dosing up to three times a day, according to Christine P. Nguyen, M.D., acting director of the FDA Division of Urology, Obstetrics and Gynecology in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the Center for Drug Evaluation and Research.
WEDNESDAY, May 27, 2020 -- Intravenous (IV) artesunate received approval from the U.S. Food and Drug Administration to treat adults and children with severe malaria, the agency announced Tuesday.
This approval marks the first for severe malaria since the marketing of quinine was discontinued in early 2019. Before the current approval, U.S. patients with severe malaria and those with uncomplicated malaria who were not able to take oral medications were treated with IV artesunate under an investigational new drug protocol through the FDA Expanded Access program.
MONDAY, May 18, 2020 -- The U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as a fourth-line treatment for adults with advanced gastrointestinal stromal tumors (GISTs), the agency announced Friday.
The approval follows four other FDA-approved target therapies for GIST, including imatinib in 2002, sunitinib in 2006, regorafenib in 2013, and avapritinib in January. Qinlock is indicated for patients who have received at least three kinase inhibitor therapies, including imatinib.
MONDAY, May 11, 2020 -- Retevmo (selpercatinib) capsules have been approved to treat patients with non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and other thyroid cancers with an alteration in the "rearranged during transfection" (RET) gene, the U.S. Food and Drug Administration announced Friday.
Retevmo was approved for adults with metastatic NSCLC and patients aged 12 years and older with advanced or metastatic MTC requiring systemic therapy or advanced RET fusion-positive thyroid cancer requiring systemic therapy that has stopped responding to or is not appropriate for radioactive iodine (RAI) therapy. Before a patient initiates Retevmo treatment, presence of the RET gene alteration must be identified through laboratory testing.
WEDNESDAY, May 6, 2020 -- The U.S. Food and Drug Administration has granted approval for Farxiga (dapagliflozin) oral tablets to treat adults with heart failure with reduced ejection fraction, the agency announced Tuesday.
Farxiga is the first approved sodium-glucose cotransporter 2 inhibitor to treat adults with New York Heart Association functional class II to IV heart failure with reduced ejection fraction. The drug is indicated to reduce the risk for cardiovascular death and hospitalization for heart failure in this patient population. Farxiga has already been FDA-approved to improve glycemic control in patients with type 2 diabetes and to reduce the risk for hospitalization in patients with type 2 diabetes and known cardiovascular disease or other risk factors.
THURSDAY, April 23, 2020 -- Accelerated approval has been granted to Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer who have received at least two previous therapies, the U.S. Food and Drug Administration announced Wednesday.
Approval of Trodelvy, a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, was based on clinical trial data from 108 breast cancer patients with metastatic triple-negative disease. Researchers found an overall response rate of 33.3 percent and a median response duration of 7.7 months. Response was maintained for six months or longer in 55.6 percent of patients who responded, and 16.7 percent of those who responded maintained response for one year or longer.
MONDAY, April 20, 2020 -- The U.S. Food and Drug Administration announced Friday the approval of Tukysa (tucatinib) in combination with trastuzumab and capecitabine for treatment of advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Tukysa, a kinase inhibitor, is indicated for patients who have already received treatment with at least one anti-HER2-based regimen in the metastatic setting. Approval was based on results of the HER2CLIMB clinical trial, which enrolled 612 patients with HER2-positive advanced unresectable or metastatic breast cancer who had previously received treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). Forty-eight percent of patients had brain metastases at trial start.
MONDAY, April 20, 2020 -- Pemazyre (pemigatinib) has been granted accelerated approval for the treatment of advanced cholangiocarcinoma, the U.S. Food and Drug Administration announced Friday.
The drug approval is indicated for previously treated patients with locally advanced or metastatic cholangiocarcinoma and tumors with a fusion or other rearrangement of fibroblast growth factor receptor 2 (FGFR2). Until now, the standard initial treatment for these patients has been a combination of chemotherapy.