Blueprint Medicines Provides 2022 Portfolio Goals Targeting Expanded Precision Therapy Leadership
"With two precision therapies expanding their global reach across multiple approved indications, four INDs filed from our portfolio in 2021, and a range of clinical data inflection points anticipated over the next 12 to 18 months,
The company's key strategies and upcoming goals are to:
1. Expand the company's leadership position in systemic mastocytosis (SM), improving treatment options for patients across the spectrum of the disease.
AYVAKIT®/AYVAKYT® (avapritinib) and BLU-263: SM
- Obtain regulatory approval from the
European Medicines Agencyand launch AYVAKYT in advanced SM in Europein the first half of 2022.
- Report topline data from the registration-enabling Part 2 of the PIONEER trial of AYVAKIT in non-advanced SM in mid-2022.
- Submit a supplemental new drug application to the
U.S. Food and Drug Administrationfor AYVAKIT in non-advanced SM in the second half of 2022.
- Present data from the HARBOR trial of BLU-263 in non-advanced SM in the second half of 2022.
2. Advance a robust portfolio of innovative clinical programs towards registration.
BLU-945 and BLU-701: EGFR-driven NSCLC
- Present preclinical data supporting the combination of BLU-945 and BLU-701 in the first quarter of 2022.
- Present initial clinical data from the Phase 1/2 SYMPHONY trial of BLU-945 in the first half of 2022.
- Present initial clinical data from Phase 1/2 HARMONY trial of BLU-701 in the second half of 2022.
BLU-451 (formerly LNG-451): EGFR exon 20 insertion-positive NSCLC
- Initiate a Phase 1/2 trial of BLU-451 in the first quarter of 2022.
- Present preclinical data for BLU-451 in the first half of 2022.
BLU-222: Cyclin-E aberrant cancers
- Initiate the Phase 1/2 VELA trial of BLU-222 in the first quarter of 2022.
- Present preclinical data for BLU-222 in the first half of 2022.
GAVRETO® (pralsetinib): RET-altered cancers
- Submit additional marketing applications for GAVRETO for RET-altered NSCLC and thyroid cancers across multiple additional global geographies in 2022, via the company's ongoing global collaboration with Roche.
3. Grow the R&D pipeline with diverse, high-value programs from company's prolific scientific platform.
- Expand pipeline with two new development candidates in 2022.
- Share the company's research vision, including scientific platform expansion plans, at an R&D Day in the second half of 2022.
1The preliminary selected financial results are unaudited, subject to adjustment, and provided as an approximation in advance of the Company's announcement of complete financial results in
Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for systemic mastocytosis, lung cancer and other genomically defined cancers. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, strategies, timelines and expectations for
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