Pfizer Inc. PFE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that two of its hematology medicines be granted marketing authorizations in the EU. However, the committee gave a negative opinion, recommending against label expansion of Pfizer’s kidney cancer medication, Sutent.
The CHMP recommended approval of Mylotarg in combination with standard chemotherapy for the treatment of patients aged 15 years and above with newly diagnosed CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL). Mylotarg was approved in the United States in September last year.
CHMP also granted a positive opinion for the label expansion of another leukemia drug Bosulif for the first-line treatment of patients suffering from chronic phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Bosulif was approved in the first-line setting for Ph+ CML in the United States in December last year.
However, the CHMP recommended against approving the label expansion of Sutent as an adjuvant treatment in patients at high risk of recurrent advanced renal cell carcinoma (RCC), following nephrectomy (surgical removal of the cancer-containing kidney).
Please note that Sutent was approved for use in the same patient population in the United States in November last year. It is the only adjuvant therapy approved for recurrent RCC, the most common type of kidney cancer.
Though the European Commission (EC) is not bound to follow the CHMP’s opinion, it usually does so.
Bosulif recorded sales of $40 million in the developed Europe region in 2017, recording growth of 43% year over year while Sutent’s sales of $323 million in the same region declined 4%.
Shares of Pfizer are up 2.4% so far this year, comparing favorably with a 0.7% increase for the industry.
Zacks Rank & Other Stocks to Consider
Pfizer carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Other large-cap pharma stocks worth considering are H. Lundbeck HLUYY, AbbVie ABBV and Novo Nordisk NVO. While H. Lundbeck sports a Zacks Rank #1 (Strong Buy), AbbVie and Novo Nordisk have the same Zacks Rank as Pfizer.
Shares of H. Lundbeck are up 5.6% this year so far while estimates for 2018 and 2019 are up 6.1% and 22.6% over the past 60 days.
AbbVie’s shares are up 25.6% this year so far. Over the past 30 days, earnings estimates have risen 8.4% and 7%, respectively, for 2018 and 2019.
Novo Nordisk’s shares are up 1.6% this year so far. Over the past 30 days, earnings estimates have risen 1.5% and 4.9%, respectively, for 2018 and 2019.
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