HealthTree for Multiple Myeloma has posted several articles over the past year about the treatment successes from both anti-BCMA CAR-T products currently available in the US market [Abecma from Bristol Myers and Carvykti from Janssen/Johnson & Johnson/Legend Biotech].
Both organizations are also conducting additional clinical studies in an effort to secure approval for earlier line of treatment (the Holy Grail to expand the market, market share and long-term revenue potential). HealthTree has also mentioned the issue of patients having to wait a long time before they can be “slotted” before their T-cells can be harvested and processed into the CAR-T cells needed to treat their relapsed disease.
It is reasonable to wonder why a leading company in the myeloma space has been caught with the problem of not being able to supply the budding market for a key product. It is an even more reasonable question to ask considering that Bristol Myers ran into the same problem(s) following the launch of their anti-BCMA CAR-T product, Abecma, launched about a year earlier than Carvykti. In other words, what lessons did Janssen/Johnson & Johnson/Legend Biotech learn from the Abecma supply issues ? I will not speculate on an answer here.
Legend Biotech’s CEO, Ying Huang, Ph.D., has recently shed some light on what is behind the tight supply for Carvykti during an investor conference. There are three principle areas that the development and commercialization partnership of J&J/Legend has discussed with respect to supply issues:
“During early launch days, J&J and Legend experienced a higher rate of manufacturing failure than they did in the CARTITUDE-1 trial used to support Carvykti’s existing FDA approval. The product release specification for commercial Carvykti that the FDA requires is more stringent than what was used in the clinical study. Besides, investigators screened patients to decide eligibility for the clinical trial, but patient baseline characteristics are more diverse in the real world. And a patient’s baseline health status affects the viability and the number of T cells collected, Huang said.”
What are J&J/Legend doing to solve the current shortage? The companies have clearly stated that major investments are being made:
Taken together, it seems as if there is “light at the end of the tunnel” and all we, myeloma patients, can do is keep our fingers crossed that these three capacity expansion programs will progress rapidly to make this exciting product available to all of us in need.
about the author
I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find successful treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and two grandsons who are the ‘lights of our lives’. Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs. I am a firm believer that staying mentally active, physically fit, compliant to our treatment regimen and taking an active interest in our disease are keys to successful treatment outcomes.