Blueprint Medicines Corporation ( BPMC Quick Quote BPMC - Free Report) have rallied 11% so far this year compared with the industry’s increase of 2.3%. The company’s lead drug Ayvakit (avapritinib) was approved by the FDA in January 2020 as a treatment of unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a PDGFRA exon 18 mutation including PDGFRA D842V mutations in adults.
Following this nod, Ayvakit became the first precision therapy to be approved by the FDA for treating genomically defined patients with GIST, a population that previously had very limited treatment options.
In September 2020, the European Commission (EC) granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation.
Ayvakyt is the first highly effective treatment option to get the EU nod for PDGFRA D842V mutant GIST, a rare form of cancer. The drug is marketed under the trade name Ayvakit in the United States.
Meanwhile, in September 2020, the company announced positive top-line data from the phase I EXPLORER and the phase II PATHFINDER studies, which evaluated Ayvakit for the treatment of patients with advanced systemic mastocytosis (SM), a rare, debilitating disease. Shares of the company rose significantly after the data release.
Blueprint Medicines plans to submit a supplemental NDA to the FDA for Ayvakit in the fourth quarter of 2020 to treat patients with advanced SM.
This apart, in the same month, Blueprint Medicines’ second precision medicine Gavreto (pralsetinib) was approved by the FDA for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The drug can be administered to patients when an FDA-approved test detects this disease.
Blueprint Medicines is co-developing Gavreto with Swiss pharma giant Roche (
RHHBY Quick Quote RHHBY - Free Report) for attending patients with various types of RET-altered thyroid cancers and other solid tumors. Both companies will co-commercialize Gavreto in the United States while Roche alone will commercialize the drug outside the United States.
Further, the FDA granted a Priority Review to Gavreto for the treatment of advanced/metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. A decision on the same is expected by Feb 28 2021.
Notably, Blueprint Medicines is riding on the success of Ayvakit as the drug is nearing a potential label expansion approval next year. In the first six months of 2020, the product generated sales worth $9.1 million. A potential approval for the SM indication should drive its sales prospects as well as the company’s stock in the future quarters. However, competition remains stiff as Deciphera Pharmaceuticals’ (
DCPH Quick Quote DCPH - Free Report) Qinlock (ripretinib) was approved by the FDA in May 2020 to treat adult patients with advanced GIST who already received prior treatment with three or more kinase inhibitors including Novartis’ ( NVS Quick Quote NVS - Free Report) Gleevec (imatinib). Zacks Rank
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). You can see
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