FDA grants full approval for TIVDAK to treat cervical cancer
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
Sales reflect continued strong growth in oncology and vaccines
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents
First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial
Application based on results from the TROPION-Breast01 Phase III trial
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
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