GAVRETO® (pralsetinib): RET-altered cancers Please click here to see the full Prescribing Information for AYVAKIT and visit for more information on AYVAKIT. AYVAKIT received its initial approval from the FDA in 2020 for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. Read the press release announcing the expansion of the FDA label for AYVAKIT into advanced SM here. Food and Drug Administration (FDA) in June 2021 for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL). Recorded $8.5 million in net product revenue during the second quarter of 2021 for AYVAKIT/AYVAKYT, which was approved by the U.S.Second Quarter 2021 Highlights and Recent ProgressĪYVAKIT™/AYVAKYT® (avapritinib): systemic mastocytosis (SM) and gastrointestinal stromal tumor (GIST) ![]() This commercial and clinical progress, combined with our financial strength, provides a robust foundation for future growth as we look to address the needs of many more patients with cancer and hematologic disorders." ![]() "In addition, we continued to progress our expanding clinical portfolio with the initiation of the Phase 1/2 trial of BLU-945, the initiation of the Phase 2/3 HARBOR trial of BLU-263 and the announcement of a strategic research collaboration with MD Anderson to accelerate the development of BLU-222, all of which exemplify the potential impact of our next wave of therapeutic candidates. approval of AYVAKIT for advanced systemic mastocytosis, and the launch of this therapy is off to a great start with broad prescriber demand," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "In the second quarter, we achieved one of our foundational corporate goals, securing U.S.
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