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Blueprint's (BPMC) Cancer Study Put on Partial Hold by FDA
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Blueprint Medicines Corporation (BPMC - Free Report) announced that the FDA placed a partial clinical hold on the phase I/II study of pipeline candidate BLU-222.
The company is developing investigational inhibitor, BLU-222, targeting CDK2 for the treatment of patients with CDK2-vulnerable cancers. The company initiated the phase I/II study, VELA, of BLU-222 in the first quarter of 2022. BLU-222 is being evaluated in the phase I dose escalation portion of the VELA trial.
The regulatory body informed the company about the hold in a verbal communication. The partial clinical hold was placed due to visual adverse events (AEs) observed in a limited number of patients. Patients currently enrolled in the trial are continuing to take the study drug at this time, but additional patients will not be enrolled until the partial clinical hold is resolved.
The reported visual AEs consisted of transient, reversible episodes of light sensitivity and blurred vision. All events were Grade 1, except one Grade 3 event involving light sensitivity and blurred vision in a patient treated at 600 mg BID. The company claims to have resolved all events involving dose interruption or reduction.
The company has stated that patients have been treated with BLU-222 at doses ranging from 50 mg BID to 800 mg BID to date, with evidence of clinical benefit observed and no discontinuations due to AEs.
Blueprint Medicines will look to amend the VELA trial protocol to provide specific guidance to investigators on how to monitor for and manage these events, should they occur. The company targets to present its initial dose escalation data from the VELA trial of BLU-222 in the first half of 2023.
In the past year, shares of Blueprint have lost 47.1% compared with the industry’s decline of 8.6%.
Image Source: Zacks Investment Research
Blueprint Medicines’ lead drug, Ayvakit (avapritinib), is a kinase inhibitor approved by the FDA for the treatment of adults with advanced systemic mastocytosis (SM), including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and adults with an unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
The FDA recently accepted the company's supplemental new drug application for Ayvakit for the treatment of adults with indolent SM. The FDA granted the application priority review with an action date of May 22, 2023.
The company’s other drug, Gavreto (pralsetinib), is approved for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
Ayvakit faces competition for the GIST indication from Deciphera Pharmaceutical’s (DCPH - Free Report) Qinlock, which is approved for advanced GIST.
Deciphera received FDA approval for Qinlock for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors back in May 2020.
Over the past 60 days, earnings estimates for Alkermes for 2022 have increased by 2 cents to 25 cents. Alkermes surpassed estimates in three of the trailing four quarters and met the same in the remaining one, the average surprise being 306.73%.
Over the past 60 days, earnings estimates for Dynavax for 2022 have increased by 11 cents to $1.95. Dynavax surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 73.15%.
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Blueprint's (BPMC) Cancer Study Put on Partial Hold by FDA
Blueprint Medicines Corporation (BPMC - Free Report) announced that the FDA placed a partial clinical hold on the phase I/II study of pipeline candidate BLU-222.
The company is developing investigational inhibitor, BLU-222, targeting CDK2 for the treatment of patients with CDK2-vulnerable cancers. The company initiated the phase I/II study, VELA, of BLU-222 in the first quarter of 2022. BLU-222 is being evaluated in the phase I dose escalation portion of the VELA trial.
The regulatory body informed the company about the hold in a verbal communication. The partial clinical hold was placed due to visual adverse events (AEs) observed in a limited number of patients. Patients currently enrolled in the trial are continuing to take the study drug at this time, but additional patients will not be enrolled until the partial clinical hold is resolved.
The reported visual AEs consisted of transient, reversible episodes of light sensitivity and blurred vision. All events were Grade 1, except one Grade 3 event involving light sensitivity and blurred vision in a patient treated at 600 mg BID. The company claims to have resolved all events involving dose interruption or reduction.
The company has stated that patients have been treated with BLU-222 at doses ranging from 50 mg BID to 800 mg BID to date, with evidence of clinical benefit observed and no discontinuations due to AEs.
Blueprint Medicines will look to amend the VELA trial protocol to provide specific guidance to investigators on how to monitor for and manage these events, should they occur. The company targets to present its initial dose escalation data from the VELA trial of BLU-222 in the first half of 2023.
In the past year, shares of Blueprint have lost 47.1% compared with the industry’s decline of 8.6%.
Image Source: Zacks Investment Research
Blueprint Medicines’ lead drug, Ayvakit (avapritinib), is a kinase inhibitor approved by the FDA for the treatment of adults with advanced systemic mastocytosis (SM), including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and adults with an unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
The FDA recently accepted the company's supplemental new drug application for Ayvakit for the treatment of adults with indolent SM. The FDA granted the application priority review with an action date of May 22, 2023.
The company’s other drug, Gavreto (pralsetinib), is approved for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
Ayvakit faces competition for the GIST indication from Deciphera Pharmaceutical’s (DCPH - Free Report) Qinlock, which is approved for advanced GIST.
Deciphera received FDA approval for Qinlock for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors back in May 2020.
Blueprint Medicines currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks are Alkermes (ALKS - Free Report) and Dynavax Technologies (DVAX - Free Report) , 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.
Over the past 60 days, earnings estimates for Alkermes for 2022 have increased by 2 cents to 25 cents. Alkermes surpassed estimates in three of the trailing four quarters and met the same in the remaining one, the average surprise being 306.73%.
Over the past 60 days, earnings estimates for Dynavax for 2022 have increased by 11 cents to $1.95. Dynavax surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 73.15%.