The approval was based on data from the phase 3 TROPiCS-02 study.
A positive SARS-CoV-2 test result is no longer required to prescribe Paxlovid and Lagevrio.
The approval was based on data from the phase 3 EMERALD study.
The approval was based on data from the phase 2 MOUNTAINEER trial, which included patients with HER2-positive. unresectable or metastatic colorectal cancer.
The approval was based on data from the phase 3 SEQUOIA and ALPINE studies in patients with CLL/SLL.
Lumoxiti was approved by the FDA in September 2018 for the treatment of adults with relapsed or refractory hairy cell leukemia.
The FDA has approved Lunsumio (mosunetuzumab-axgb) to treat adults with relapsed/refractory follicular lymphoma after 2 or more lines of systemic therapy.
Rezlidhia (olutasidenib) is now available for the treatment of adults with relapsed or refractory acute myeloid leukemia and a susceptible IDH1 mutation.
The approval was supported by data from 4 trials.
The approval was based on data from the phase 3 ELUCIDATE study.
