FDA issued a safety communication Aug. 20 that included new recommendations for IRBs and investigators studying robotically-assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of breast cancer.
Genentech has withdrawn the U.S. accelerated approval indication for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1, as determined by an FDA)-approved test.
Tibsovo (ivosidenib) has received FDA approval for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
Opdivo (nivolumab) has received FDA approval (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.
Jemperli (dostarlimab-gxly) has received accelerated approval from FDA for adult patients with mismatch repair deficient recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, has received FDA approval for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Keytruda plus Lenvima have received FDA approval as first-line treatment of adult patients with advanced renal cell carcinoma.
FDA has accepted for review a supplemental Biologics License Application seeking approval for Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
FDA has accepted and granted priority review to the New Drug Application for asciminib (ABL001) in chronic myeloid leukemia.
The European Commission has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
