Amgen Inc. (AMGN - Free Report) announced that Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending approval for a new indication of Blincyto in Europe. Amgen is looking to get approval to expand the European label of Blincyto to include treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (“ALL”).
It is to be noted that the CHMP had provided a negative opinion for this label expansion earlier in July following which Amgen requested a re-examination.
The drug is already approved for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL in Europe as well as United States.
Blincyto was approved for the MRD-positive B-cell precursor ALL indication in the United States in March this year. Blincyto will become the first drug in Europe for the treatment of MRD in ALL patients, upon potential approval.
Amgen’s shares are up 11.6% so far this year compared with the industry’s decline of 18.6%.
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 78% of the patients within one treatment cycle.
We note that MRD refers to detectable cancer cells in patients who have achieved complete remission by conventional treatment methods. Consequently, the treatment of MRD will enable in achieving better possible clinical outcomes in patients by delaying or stopping relapse of ALL by destroying the remaining detectable traces of leukemia.
Blincyto has shown an impressive sales growth rate of almost 30% in the first nine months of 2018, with sales reaching $167 million. Sales are expected to improve further in the fourth quarter on the back of continued demand. However, the impact of expansion of label to include treatment of MRD has not been meaningful in the United States so far.
We remind investors that Blincyto competes with Pfizer Inc.’s (PFE - Free Report) Besponsa which is approved for the treatment of relapsed or refractory B-cell precursor ALL in the United States and Europe.
Zacks Rank & Stocks to Consider
Amgen currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Gilead Sciences, Inc. (GILD - 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.
Alexion’s earnings estimates increased from $7.23 to $7.61 for 2018 and $8.59 to $8.77 for 2019 over the last 30 days. The company delivered a positive earnings surprise in the four trailing quarters with average beat of 16.77%.
Gilead’s earnings per share estimates increased from $6.63 to $6.87 for 2018 and $6.58 to $6.75 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with average beat of 6.99%.
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