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The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
In its second quarter 2018 earnings call held on July 18, 2018, Novartis executives discussed a production issue that the company has encountered for its chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), when producing the therapy to treat diffuse large B-cell lymphoma (DLBCL). FDA granted Kymriah approval for this second indication in May 2018.
The production glitch centers around the variability in product specification for the therapy; the product does not meet commercial specifications in the DLBCL indication at this time. This is due to the fact that the CAR-T therapy is manufactured individually for each patient using the patient's own T cells, as stated by Novartis.
“On manufacturing, we have seen some variability in our product specifications. This is something we’re looking at now in DLBCL to make sure that we can continue to ramp up the demand. We feel confident in the overall longer-term outlook for Kymriah,” said Vas Narasimhan, CEO, Novartis, in the second-quarter earnings call.
“The variability that we’ve seen in the commercial specifications, which isn’t unusual with a new therapy as you launch it into a new target patient population, is that we have still been able to deliver final product to the majority of patients. It is really more of a specification [issue], and we’re working directly with FDA on trying to solve the issue as well as looking at new ways to improve our output to meet more commercial specification on Kymriah,” added Liz Barrett, CEO, Novartis Oncology, in the earnings call.
In an emailed statement issued by Novartis, the company said:
“Since the FDA approval of Kymriah in August 2017, Novartis has been delivering treatment for pediatric and young adult acute lymphoblastic leukemia (ALL) patients with a high level of success. With the recent introduction of the diffuse large B-cell lymphoma (DLBCL) indication, we have identified variability in meeting final product commercial specifications in DLBCL and are working to resolve this as soon as possible. Our priority goal is to provide this transformative product to patients in both indications, and we have been able to deliver Kymriah to the majority of our patients.
Novartis is committed to sharing this information with treating physicians, so they can make the best decision with their patients. For cases where the product does not meet commercial specifications, we have developed an Expanded Access Program path to deliver treatment, when possible.
We are committed to resolving this as quickly as possible and to serving all patients who may be able to benefit from this transformative therapy.”