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Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients


Novartis’ plans to expand the use of its CAR-T therapy Kymriah look rosier after the FDA and EMA both said they would carry out speedy reviews of new indications.

In the US, the Swiss pharma firm gets a priority review for Kymriah (tisagenlecleucel) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT).

Meanwhile, in Europe it will get an accelerated assessment from the EMA for the treatment of children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL), as well as in adults with relapsed or refractory DLBCL who are ineligible for ASCT.

CAR-T is a new approach to immuno-oncology that uses modified versions of a patient's own white blood cells to attack cancer, homing in one tumour-associated antigens.

Approval would lead to a sizeable expansion in the eligible patient population for Kymriah, which is a key part of Novartis’ strategy in oncology at a time when older drugs such as Glivec (imatinib) are succumbing to generic competition.

The cell-based cancer immunotherapy was approved in the US last August for the ALL indication, shortly before CAR-T rival Kite Pharma (now part of Gilead Sciences) got a green light from the FDA and EMA last year for its Yescarta (axicabtagene ciloleucel) therapy for adults with various types of B-cell lymphoma, including relapsed or refractory DLBCL.

If Novartis gets approval for DLBCL it could be the first time that the two products will compete head-to-head in the marketplace, although there’s a slew of new candidates coming through the pipeline, including JCAR017, a DLBCL CAR-T in the final stage of clinical development from Juno, which is rumoured to be a takeover target for Celgene.

Novartis said that it is working with the regulators to “make Kymriah available to more patients with critical unmet need”.

CAR-Ts come with hefty price tags - Novartis has set a list price of $475,000 in ALL, with a refund on offer if it doesn’t provide the expected clinical benefit, while Yescarta costs $373,000 for DLBCL - but the Swiss pharma firm has said it may price the drug differently in other indications.

Novartis said it plans additional regulatory submissions for Kymriah in paediatric and young adult patients with B-cell ALL and adult patients with DLBCL beyond the US and EU in 2018.

Article by
Phil Taylor

18th January 2018

From: Regulatory



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