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Amgen's Blincyto Gets FDA Nod for Minimum Residual Disease
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Amgen Inc. (AMGN - Free Report) announced that the FDA has granted accelerated approval for a new indication of leukemia drug, Blincyto. With the FDA approving the latest supplemental biologics license application (sBLA), Blincyto’s label is expanded to include treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (“ALL”).
With this approval, Blincyto becomes the first FDA-approved drug for the treatment of MRD in ALL patients. However, continued approval in this indication is subject to clinical benefit data from confirmatory studies.
The drug is already approved for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL in the United States and Europe.
Amgen’s shares are down 1.9% so far this year compared with the industry’s loss of 4.9% during the period.
The approval was based on data from phase II BLAST study, evaluating Blincyto in MRD-positive ALL patients who have achieved complete hematologic remission after receiving three or more cycles of intensive chemotherapy. Data showed that the drug achieved complete MRD response (no detectable MRD) in 81% of the patients. Median hematological relapse-free survival rate for the drug was 22.3 months.
We note that MRD refers to detectable cancer cells in patients who have achieved complete remission by conventional treatment methods. Hence, the treatment of MRD will help to achieve better possible clinical outcomes in patients and delaying or stopping relapse of ALL by destroying the remaining detectable traces of leukemia.
Blincyto has shown an impressive growth rate of 52% in 2017, with sales reaching $175 million. Sales are expected to improve further this year due to continued demand. However, the impact of expansion of label to include treatment of MRD remains to be seen.
We remind investors that Pfizer Inc.’s (PFE - Free Report) Besponsa had received approval for the treatment of relapsed or refractory B-cell precursor ALL in August 2017 in the United States, increasing competition for Blincyto.
Horizon Pharma’s earnings estimates increased 10% to $1.43 for 2018 and 15% to $1.77 for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 68.92%.
Ligand’s earnings per share estimates increased 11% to $4.20 for 2018 and 12% to $5.32 for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 24.88%. The company’s shares have increased 20.6% so far this year.
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Amgen's Blincyto Gets FDA Nod for Minimum Residual Disease
Amgen Inc. (AMGN - Free Report) announced that the FDA has granted accelerated approval for a new indication of leukemia drug, Blincyto. With the FDA approving the latest supplemental biologics license application (sBLA), Blincyto’s label is expanded to include treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (“ALL”).
With this approval, Blincyto becomes the first FDA-approved drug for the treatment of MRD in ALL patients. However, continued approval in this indication is subject to clinical benefit data from confirmatory studies.
The drug is already approved for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL in the United States and Europe.
Amgen’s shares are down 1.9% so far this year compared with the industry’s loss of 4.9% during the period.
The approval was based on data from phase II BLAST study, evaluating Blincyto in MRD-positive ALL patients who have achieved complete hematologic remission after receiving three or more cycles of intensive chemotherapy. Data showed that the drug achieved complete MRD response (no detectable MRD) in 81% of the patients. Median hematological relapse-free survival rate for the drug was 22.3 months.
We note that MRD refers to detectable cancer cells in patients who have achieved complete remission by conventional treatment methods. Hence, the treatment of MRD will help to achieve better possible clinical outcomes in patients and delaying or stopping relapse of ALL by destroying the remaining detectable traces of leukemia.
Blincyto has shown an impressive growth rate of 52% in 2017, with sales reaching $175 million. Sales are expected to improve further this year due to continued demand. However, the impact of expansion of label to include treatment of MRD remains to be seen.
We remind investors that Pfizer Inc.’s (PFE - Free Report) Besponsa had received approval for the treatment of relapsed or refractory B-cell precursor ALL in August 2017 in the United States, increasing competition for Blincyto.
Amgen Inc. Price
Amgen Inc. Price | Amgen Inc. Quote
Zacks Rank & Stocks to Consider
Amgen currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector include Horizon Pharma Public Limited Company and Ligand Pharmaceuticals Incorporated (LGND - Free Report) ). Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Horizon Pharma’s earnings estimates increased 10% to $1.43 for 2018 and 15% to $1.77 for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 68.92%.
Ligand’s earnings per share estimates increased 11% to $4.20 for 2018 and 12% to $5.32 for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 24.88%. The company’s shares have increased 20.6% so far this year.
Can Hackers Put Money INTO Your Portfolio?
Earlier this month, credit bureau Equifax announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
Download the new report now>>