Amgen AMGN announced that the FDA has approved a supplemental biologics license application (sBLA) for a three-drug combination regimen of its blockbuster multiple myeloma (“MM”) drug, Kyprolis. The sBLA sought label expansion of Kyprolis in combination with J&J’s JNJ MM drug, Darzalex, and dexamethasone (DKd) as second to fourth-line treatment option for patients with relapsed/refractory (r/r) MM. The combo therapy will be available in two dosing regimens — once weekly and twice weekly.
The recent approval was based on encouraging data from the phase III CANDOR study, which demonstrated improvement in progression-free-survival in patients receiving DKd combo compared to Kyprolis plus dexamethasone (Kd) alone. Treatment with DKd led to a reduction in the risk of progression or death by 37% in patients with relapsed or refractory MM.
Please note that three different Kyprolis combination regimens are already approved for treating r/rMM in similar treatment setting. Kyprolis is also approved as monotherapy for r/rMM in second or later-line settings.
The Kyprolis combination regimen is under review in China for a similar indication. Amgen has a collaboration with BeiGene BGNE for commercialization of Kyprolis n China.
Shares of Amgen have declined 1% so far this year against the industry’s increase of 2.7%.
Kyprolis recorded sales of $533 million in the first half of 2020, reflecting growth of 4.1% year over year. We note that sales of the drug were adversely impacted due to lower multiple myeloma patient visits to doctors amid coronavirus-related travel restrictions.
Meanwhile, we note that Kyprolis is facing increased competition from other available MM drugs including Bristol-Myers Squibb’s BMY Revlimid and Pomalyst, and several recently approved products. Moreover, two generic drugmakers are trying to get approval for a generic version of Kyprolis. Label expansion of the drug in different combination regimens and treatment settings are likely to help the company to offset some of these competitions.
Zacks Rank
Amgen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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