FDA accepted a supplemental New Drug Application and granted Priority Review for Tibsovo (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1-mutated relapsed or refractory myelodysplastic syndromes. If approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset.
FDA granted accelerated approval to Talvey (talquetamab-tgvs) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA granted regular approval to Gavreto (pralsetinib) for adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA-approved test.
FDA approved the therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors who may be eligible for treatment with Ayvakit (avapritinib).
FDA accepted the supplemental New Drug Application for Cresemba (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal drug, seeking approval for the treatment of invasive aspergillosis or invasive mucormycosis in pediatric patients aged one to 17 years old.
FDA has approved Jemperli (dostarlimab-gxly) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.
FDA has approved Lonsurf (trifluridine and tipiracil) with bevacizumab, for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
FDA and CTTI announced a call for applications for new members of the Patient Engagement Collaborative. The PEC is an ongoing, shared forum in which the patient community (PEC members), FDA, and CTTI discuss a variety of topics such as improving communication, education, and patient engagement related to medical product regulation.
FDA has approved quizartinib (Vanflyta) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test.
FDA has granted Fast Track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer upon progression on an androgen receptor pathway inhibitor.
