BLUEPRINT MEDICINES TRIAL
Present dose escalation data from the VELA trial of BLU-222 in patients with CDK2-vulnerable cancers in the first half of 2023.Present dose escalation data from the CONCERTO trial of BLU-451 in EGFR exon 20 insertion-positive NSCLC in the first half of 2023.Receive approval from the FDA for AYVAKIT for use in adults with ISM in the second quarter of 2023.Present registrational PIONEER trial data in ISM at the AAAAI annual meeting in the first quarter of 2023.The company plans to achieve the following milestones by mid-2023: Announced the appointment of John Tsai, M.D, former President, Global Drug Development and Chief Medical Officer at Novartis AG, to the company's Board of Directors.Presented the company's 2027 Blueprint to achieve Precision at Scale, a five-year business strategy to double the company's impact at Investor Day 2022.Presented new data supporting BLU-222 as monotherapy or in combination with ribociclib in preclinical models at San Antonio Breast Cancer Symposium.Announced a partial clinical trial hold for the Phase 1/2 VELA study of BLU-222 due to transient and reversible visual adverse events observed in a limited number of patients.Presented new preclinical data supporting the development of BLU-525 as a potent and selective EGFR inhibitor at the AACR-NCI-EORTC meeting.
This included data demonstrating that BLU-945 monotherapy treatment led to ctDNA responses and tumor shrinkage in late-line patients with EGFR-driven NSCLC, as well as early dose escalation data showing BLU-945 in combination with osimertinib has been generally well-tolerated to-date. Presented new clinical data at the company's Investor Day informing the development strategy for BLU-945, including plan to prioritize development of BLU-945 in combination with osimertinib in first-line EGFR L858R-positive NSCLC.
Read the press release here.ĮGFR-driven non-small cell lung cancer (NSCLC)
Anticipate $130 million to $140 million in AYVAKIT net product revenues in 2023 for advanced systemic mastocytosis (SM) and GIST.
BLUEPRINT MEDICINES FULL
Recorded global AYVAKIT®/AYVAKYT® (avapritinib) net product revenues of $111.0 million and $30.1 million for the full year and the fourth quarter of 2022, respectively, representing more than 100 percent year-over-year growth.
BLUEPRINT MEDICINES DRIVERS
"In 2023, Blueprint Medicines has a diversity of fundamental value drivers that position us well on the path to achieve our 2027 Blueprint for Precision at Scale and translate the promise of precision medicine into reality for thousands of patients globally."įourth Quarter 2022 Highlights and Recent Progress In addition to our commercial execution, we advanced additional clinical development programs and continued to bolster our financial strength through our strategic financing and business development," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. Today, we are at the precipice of a pivotal moment in Blueprint's history as we near a potential FDA approval of AYVAKIT for a much broader population of patients with indolent SM, which will enable us to address the significant medical needs of SM patients and create a critical inflection point in our growing revenue stream. "In 2022, AYVAKIT became the standard of care for patients with advanced systemic mastocytosis in the U.S., and we continued to solidify our global leadership in mast cell disorders.
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