Johnson & Johnson
JNJ
announced that the European Commission (EC) has granted conditional marketing authorization to its BCMA-directed CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel or cilta-cel) for treating advanced multiple myeloma.
Following the approval, Carvykti can be given in Europe to adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including treatment with three major classes of multiple myeloma drugs, a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Carvykti was approved in the United States in February this year for adults with RR multiple myeloma who had already received four or more lines of therapy.
The approval was based on data from the pivotal CARTITUDE-1 study. In the study, 98% of the patients who received a single infusion of cilta-cel responded to the treatment (overall response rate), while 80% of those who responded to treatment experienced a complete response, which means the patients did not show signs or symptoms of the disease.
Multiple myeloma patients for whom the three major drug classes of treatment regimens stop working experience poor survival. Carvykti works with a different mechanism of action by targeting a protein on myeloma cells called BCMA. In the heavily pre-treated patient population, a single infusion of Carvykti led to durable responses, which means the drug can be an important treatment option for such patients.
This year so far, J&J’s shares have risen 4.9% compared with an increase of 5.7% for the
industry
.
Image Source: Zacks Investment Research
J&J has a worldwide license and collaboration agreement with Legend Biotech to develop ciltacabtagene autoleucel.
Another BCMA-directed CAR-T cell therapy already approved in the United States as well as Europe is
bluebird bio
BLUE
and partner
Bristol Myers
’
BMY
Abecma (idecabtagenevicleucel).
bluebird bio and Bristol-Myers’s Abecma was approved in the United States in March 2021 and in Europe in August 2021. bluebird bio and Bristol-Myers’s Abecma was the first anti-BCMA CAR T cell immunotherapy approved for treating advanced R/R multiple myeloma.
Zacks Rank and Stock to Consider
J&J currently has a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
A better-ranked biotech stock is
Alkermes
ALKS
, which has a Zacks Rank of 2 (Buy).
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 26.2% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
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