An ODAC Meeting for Carvykti (CAR-T) for Multiple Myeloma Treatment Announced

Johnson and Johnson will undergo the same fate as their rival Bristol Myers Squibb when their CAR T-cell therapy product for earlier lines of therapy in multiple myeloma treatment is investigated in an ODAC meeting with the FDA. 

We covered Abecma's upcoming ODAC meeting last week and explained the purpose and format of ODAC meetings. Check it out here: An ODAC Meeting for Abecma (CAR-T) for Triple-Class Exposed Multiple Myeloma

This week, we learned that Johnson and Johnson's myeloma CAR-T product, known commercially as Carvykti, will also be investigated in an ODAC meeting on March 15, 2024. This will be an all-day, online meeting, and you can learn more details about the day here: March 15, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

What will happen at the ODAC meeting? 

An advisory committee will discuss the sBLA (supplemental biologics license application) for CARVYKTI. The indication that they will be investigating is for multiple myeloma patients who have received at least one line of therapy. This line of therapy needs to include a proteasome inhibitor and an immunomodulatory agent, and the patients who qualify are refractory to lenalidomide. 

What data is being investigated? 

The committee will take a closer look at the CARTITUDE-4 (Phase III clinical trial) data, especially concerning the overall survival data points of said patients who participated in the trial. They will also look at the risks and benefits of cilta-cel therapy in the intended patient population. 

Will the Abecma information be investigated at the same meeting? 

The committee will focus on the CARVYKTI data in the morning and shift to the Abecma information (focusing on overall survival data from the phase III KarMMa-3 study) that afternoon. 

How will the outcome of this meeting affect myeloma patients? 

As a reminder, the recommendation of the ODAC does not determine the final decision of the FDA. It could be that the ODAC decides to recommend CARVYKTI be approved for myeloma patients after one line of therapy, and the FDA still decides not to approve the drug (or vice versa).

However, if the FDA does approve CARVYKTI for multiple myeloma patients, this would be an encouraging step in the right direction to get prime myeloma treatments in earlier lines of therapy, perhaps reaching patients before major T-cell exhaustion or serious issues of infection that have affected patients receiving this same treatment in later lines of therapy. 

Stay tuned as we will announce the ODAC meeting results as we have them.