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Amgen's Leukemia Drug Accepted for Priority Review by FDA
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Amgen Inc. (AMGN - Free Report) recently announced that its supplemental biologics license application (sBLA) for its leukemia immunotherapy, Blincyto, has been accepted for priority review by the FDA. The company intends to expand Blincyto’s label for the treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The FDA has set a prescription drug user fee act (PDUFA) target action date of Aug 14, 2017. Blincyto gained accelerated FDA approval in Dec 2014 for the aforesaid indication. The application aims for the conversion of Blincyto's accelerated approval to full approval.
We note that Blincyto was added to Amgen’s portfolio with the Mar 2012 acquisition of biotech company, Micromet. It is the first and only FDA-approved CD19-directed CD3 bispecific T cell engager (BiTE) antibody. In Nov 2015, it was granted conditional marketing authorization in the EU for the same indication.
Amgen’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. Shares of the company gained 11.5% while the industry registered an increase of 6%.
Coming back to the latest news, the sBLA was supported by positive data from the confirmatory phase III TOWER study (n=405). The study was conducted to support the conversion of Blincyto's accelerated approval to full approval. The study evaluated the efficacy of Blincyto versus standard of care (SOC) chemotherapy for the treatment of Ph-relapsed or refractory B-cell precursor ALL in adults. The study demonstrated statistically significant improvement in overall survival (OS) over SOC chemotherapy, almost doubling median OS. The median OS was 7.7 months for Blincyto Vs four months for SOC.
Moreover, the sBLA includes new data from a phase II ALCANTARA study (n=45) evaluating the efficacy and tolerability of Blincyto in adult patients with Ph+ relapsed or refractory B-cell precursor ALL. The study showed that 31% of patients achieved complete remission with full hematologic recovery and 36% of patients achieved the same with partial hematologic recovery. The results of the study were published in the Journal of Clinical Oncology.
A Phase II study in patients with diffuse large B-cell lymphoma is underway.
We remind investors that in Sep 2016, Amgen’s sBLA for Blincyto to include new data supporting the treatment of pediatric patients with Ph-relapsed or refractory B-cell precursor ALL was approved by the FDA.
In 2016, Blincyto sales surged 49% from the year-ago period to $115 million, reflecting higher demand. Amgen announced fourth quarter and full-year 2016 results on Feb 2. It surpassed sales and earnings expectations yet again in the fourth quarter. However, the 2017 sales outlook was somewhat unimpressive.
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
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Amgen's Leukemia Drug Accepted for Priority Review by FDA
Amgen Inc. (AMGN - Free Report) recently announced that its supplemental biologics license application (sBLA) for its leukemia immunotherapy, Blincyto, has been accepted for priority review by the FDA. The company intends to expand Blincyto’s label for the treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The FDA has set a prescription drug user fee act (PDUFA) target action date of Aug 14, 2017. Blincyto gained accelerated FDA approval in Dec 2014 for the aforesaid indication. The application aims for the conversion of Blincyto's accelerated approval to full approval.
We note that Blincyto was added to Amgen’s portfolio with the Mar 2012 acquisition of biotech company, Micromet. It is the first and only FDA-approved CD19-directed CD3 bispecific T cell engager (BiTE) antibody. In Nov 2015, it was granted conditional marketing authorization in the EU for the same indication.
Amgen’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. Shares of the company gained 11.5% while the industry registered an increase of 6%.
Coming back to the latest news, the sBLA was supported by positive data from the confirmatory phase III TOWER study (n=405). The study was conducted to support the conversion of Blincyto's accelerated approval to full approval. The study evaluated the efficacy of Blincyto versus standard of care (SOC) chemotherapy for the treatment of Ph-relapsed or refractory B-cell precursor ALL in adults. The study demonstrated statistically significant improvement in overall survival (OS) over SOC chemotherapy, almost doubling median OS. The median OS was 7.7 months for Blincyto Vs four months for SOC.
Moreover, the sBLA includes new data from a phase II ALCANTARA study (n=45) evaluating the efficacy and tolerability of Blincyto in adult patients with Ph+ relapsed or refractory B-cell precursor ALL. The study showed that 31% of patients achieved complete remission with full hematologic recovery and 36% of patients achieved the same with partial hematologic recovery. The results of the study were published in the Journal of Clinical Oncology.
A Phase II study in patients with diffuse large B-cell lymphoma is underway.
We remind investors that in Sep 2016, Amgen’s sBLA for Blincyto to include new data supporting the treatment of pediatric patients with Ph-relapsed or refractory B-cell precursor ALL was approved by the FDA.
In 2016, Blincyto sales surged 49% from the year-ago period to $115 million, reflecting higher demand. Amgen announced fourth quarter and full-year 2016 results on Feb 2. It surpassed sales and earnings expectations yet again in the fourth quarter. However, the 2017 sales outlook was somewhat unimpressive.
Amgen Inc. Price
Amgen Inc. Price | Amgen Inc. Quote
Zacks Rank & Key Picks
Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>