Amgen Inc.’s (AMGN) talimogene laherparepvec, currently under FDA review for the treatment of patients with injectable regionally or distantly metastatic melanoma, will be reviewed jointly by the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee. The FDA panel meeting is scheduled for Apr 29.
Meanwhile, a final decision from the FDA regarding the approval status of the candidate should be out by Oct 27, 2015. Amgen is also looking to get talimogene laherparepvec approved in the EU where a marketing application has been filed.
According to the World Health Organization, about 132,000 melanoma cases occur globally each year.
We note that Amgen also has an agreement with Merck & Co (MRK) under which talimogene laherparepvec will be evaluated in combination with Merck’s approved anti-PD-1 therapy, Keytruda, in patients with regionally or distantly metastatic melanoma. A study was initiated late last year to evaluate the safety and efficacy of the combination treatment.
Apart from talimogene laherparepvec, other important candidates in Amgen’s pipeline include Repatha (dyslipidemia, under global regulatory review), brodalumab (asthma and moderate-to-severe plaque psoriasis) and AMG 416 (secondary hyperparathyroidism).
We are positive on Amgen’s efforts to drive growth and boost its pipeline through deals and label expansion of its products. Last month, the company had entered into a collaboration with Kite Pharma (KITE) to develop and commercialize the next generation of novel chimeric antigen receptor (CAR) T cell therapies. Meanwhile, Amgen is trying to expand the label of its multiple myeloma drug – Kyprolis, for which it has submitted an application in both U.S. and EU recently.
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is BioMarin Pharmaceutical (BMRN), sporting a Zacks Rank #1 (Strong Buy).
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