FDA approved Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Laleh Amiri-Kordestani was named acting associate director for cardio-oncology in the FDA Oncology Center of Excellence. She will also continue her role as the division director for the Division of Oncology 1.
FDA granted accelerated approval to Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
FDA approved Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
FDA granted first marketing clearance for RefleXion Medical’s SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers.
FLAG-003, an investigational small molecule therapy developed by FLAG Therapeutics Inc. for the treatment of diffuse intrinsic pontine glioma—a rare, highly aggressive and difficult to treat brain tumor found in children—has been granted Rare Pediatric Disease designation from FDA.
The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).
Sens. Chuck Grassley (R-IA), Dick Durbin (D-IL), chair of the Senate Judiciary Committee, Thom Tillis (R-NC), and Chris Coons (D-DE) to introduce bipartisan legislation that would establish a task force between the United States Patent and Trademark Office and FDA to improve communication and coordination in implementing each agency’s activities related to patents.
FDA approved Keytruda (pembrolizumab) for adjuvant treatment following resection and platinum-based chemotherapy for stage 1B, 2, or 3A non-small cell lung cancer.
FDA approved Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma.
