Tecartus and Ianalumab receive GIFT designation

Will receive fast-track review due to GIFT designation

Innovative therapies from Gilead and Novartis

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The Ministry of Food and Drug Safety (MFDS) has designated two innovative rare disease therapies attracting global attention for its Global Innovative products on Fast Track (GIFT) program, accelerating efforts to expand treatment options for patients in Korea.

According to the MFDS in July, Gilead Sciences Korea's CAR-T therapy Tecartus Inj (brexucabtagene autoleucel) and Novartis Korea's investigational Sjögren's disease treatment ianalumab have been designated as the 73rd and 74th GIFT products, respectively. The designation qualifies both products for expedited regulatory review during the marketing authorization process.

‘Tecartus Inj,’ which has also been designated an advanced biopharmaceutical, is indicated for adults with relapsed or refractory mantle cell lymphoma (MCL) and B-cell acute lymphoblastic leukemia (ALL). The MFDS granted GIFT designation after determining that the therapy offers substantially improved efficacy and safety compared with existing treatment options. Tecartus received regulatory approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020.

Novartis Korea's ianalumab is a monoclonal antibody currently being developed for adults with moderate to severe Sjögren's disease. The drug targets the BAFF receptor, inhibiting B-cell survival. Given the lack of adequate treatment options for the disease, the MFDS granted GIFT designation on the basis that ‘no available therapy’ currently exists. The product has also received Fast Track designation from the US FDA.

Both products have already been designated as orphan drugs in Korea and will undergo the MFDS's expedited review process for their approved indications and marketing authorization.

Products designated under the GIFT program benefit from a review period approximately 25% shorter than that of the standard review process. Sponsors are also eligible for ‘rolling review,’ under which completed portions of the application are reviewed as they become available, as well as tailored consultations with dedicated reviewers before submitting a marketing application. These measures are expected to significantly accelerate the introduction of innovative therapies into the Korean market.

An MFDS official said, "Through GIFT designation, we expect to accelerate the introduction of innovative medicines developed by both pharmaceutical companies in Korea and abroad, thereby providing patients with rare and intractable diseases with faster access to new treatment options."