We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Amgen's New Kyprolis Combo Gets FDA Nod for Multiple Myeloma
Read MoreHide Full Article
Amgen (AMGN - Free Report) 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 - Free Report) 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 - Free Report) 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 - Free Report) 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.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
Image: Shutterstock
Amgen's New Kyprolis Combo Gets FDA Nod for Multiple Myeloma
Amgen (AMGN - Free Report) 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 - Free Report) 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 - Free Report) 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 - Free Report) 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.
Amgen Inc. Price
Amgen Inc. price | Amgen Inc. Quote
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.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
Click here for the 6 trades >>