Blueprint Medicines Corporation
BPMC
announced that the FDA has approved Gavreto (pralsetinib) for the treatment of patients with advanced/metastatic rearranged during transfection (“RET”)-mutant and RET fusion-positive thyroid cancer.
The accelerated label expansion nod was based on safety and efficacy data from the phase I/II ARROW study, which evaluated Gavreto for the given indication. Data from the same showed that treatment with once-daily Gavreto led to robust efficacy in patients with RET-altered thyroid cancers along with prolonged duration of response. Moreover, the drug demonstrated durable efficacy and was generally well-tolerated in patients with RET-altered thyroid cancers regardless of prior systemic therapy.
Per the company, this FDA approval expands the label of Gavreto to treat pediatric and adult patients aged 12 years and above, either with advanced RET-mutant medullary thyroid cancer who require systemic therapy, or with metastatic RET fusion-positive thyroid cancer requiring systemic therapy and who are radioactive iodine-refractory.
The label expansion for Gavreto should boost the drug’s sales in the days ahead.
We remind investors that the approval comes much before the scheduled Prescription Drug User Fee Act action date of Feb 28, 2021. The regulatory application for Gavreto was accepted for review under the FDA’s Real-Time Oncology process and was also granted a priority review.
Shares of Blueprint Medicines have rallied 31.9% so far this year compared with the
industry
’s increase of 3.4%.
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Gavreto is a once-daily oral precision therapy that selectively inhibits RET-altered cancers. In September 2020, the FDA
approved
Gavreto for the treatment of adults with metastatic RET fusion-positive non-small-cell lung cancer (“NSCLC”). The drug can be administered to patients when an FDA-approved test detects this disease.
Meanwhile, the European Medicines Agency validated the marketing application for Gavreto for the treatment of RET fusion-positive NSCLC.
We remind investors that Blueprint Medicines is co-developing Gavreto with Genentech, a wholly owned subsidiary of Swiss pharma giant
Roche
RHHBY
, for addressing various types of RET-altered thyroid cancers as well as other cancer indications.
Both companies will co-commercialize Gavreto in the United States while Roche alone will commercialize the drug in other countries.
Zacks Rank & Stocks to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include
Catalyst Biosciences, Inc.
CBIO
and
Aptose Biosciences, Inc.
APTO
, both carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Catalyst Biosciences’ loss per share estimates have narrowed 13.2% for 2020 and 7.7% for 2021 over the past 60 days.
Aptose Biosciences’ loss per share estimates have narrowed 10.3% for 2020 and 4.7% for 2021 over the past 60 days. The stock has rallied 23.8% year to date.
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