The European Commission granted marketing authorization for Ebvallo (tabelecleucel) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
Caris Life Sciences and Xencor, Inc. expanded their collaboration to research, develop, and commercialize novel XmAb bispecific and multi-specific antibodies directed against novel targets, identified and proposed by Caris, for the treatment of patients with cancer.
C2i Genomics extended its collaboration with AstraZeneca to evaluate the potential of whole-genome minimal residual disease testing across solid cancers, with the goal of enhancing oncology treatment, supporting clinical trial recruitment, and monitoring.
Mersana Therapeutics Inc. and a subsidiary of Merck KGaA in Darmstadt, Germany, formed a research collaboration and commercial license agreement to discover novel Immunosynthen antibody-drug conjugates directed against up to two targets.
Gilead Sciences Inc. and Jounce Therapeutics Inc. amended their existing license agreement for GS-1811 (formerly JTX-1811), enabling Gilead to buyout remaining contingent payments potentially due under the license agreement executed in August 2020.
FDA approved updated labeling for Xeloda (capecitabine) tablets under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
FDA approved Tecentriq (atezolizumab) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma.
FDA has granted an accelerated approval to Krazati (adagrasib), a RAS GTPase family inhibitor, for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
FDA has approved Rezlidhia (olutasidenib) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.
The European Commission approved Libtayo (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.