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.
C2i Genomics and the Tel Aviv Sourasky Medical Center (Ichilov) entered into a strategic collaboration to provide precision oncology clinical testing using C2inform, C2i Genomics’s whole genome minimal residual disease test to improve cancer detection and monitoring nationwide.
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.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage 2B or 2C melanoma.
European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The final European Commission decision on this indication for Tepkinly is anticipated later this year.
MD Anderson Cancer Center and Nexo Therapeutics have entered a multi-year strategic collaboration that aligns the technology and capabilities of each organization at the earliest stages of drug discovery and development, with the aim of advancing cancer therapies against previously undruggable targets.
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.
