The approval is based on the results from the Phase III IMspire150 study, in which patients treated with the three-drug combination had an improvement in progression-free survival.
Merck announced that the FDA accepted supplemental biologic license applications for the checkpoint inhibitor for early- and later-stage triple-negative breast cancer.
The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
Through the partnership, Strata will use its next-generation sequencing test to identify advanced cancer patients with mutations in the MAPK signaling pathway.
The partners are hoping to leverage their expertise to advance drugs with a novel mechanism of action that will target a broader range of RAS mutations.
Qualigen Therapeutics will acquire intellectual property rights to the family of RAS-targeting small molecules and pay royalties to Louisville upon commercialization.
The Phase II trial in China will enroll 106 NSCLC patients with ROS1 fusions who have either never received a tyrosine kinase inhibitor or have received Xalkori.
This is the fifth neratinib approval for Puma's licensing partner STA, which is also commercializing the drug in Australia, New Zealand, Singapore, and Brunei.
