Takeda Pharmaceutical Company Ltd

Takeda secures Japanese MHLW approval for FRUZAQLA capsules to treat advanced or recurrent colorectal cancer, based on FRESCO-2 trial results showing significant improvement in overall survival and progression-free survival.

Fruquintinib (Fruzaqla) approved in Japan for advanced or recurrent colorectal cancer after chemotherapy. Based on FRESCO-2 trial, fruquintinib showed improved progression-free and overall survival vs placebo. Common adverse effects include hypertension, asthenia, and hand-foot syndrome.

HUTCHMED announces Takeda's approval from Japan's MHLW to manufacture and market FRUZAQLA® (fruquintinib) for previously treated metastatic colorectal cancer (CRC), marking the first novel targeted therapy approved in Japan for metastatic CRC in over a decade. CRC is the most prevalent cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023. The approval was based on results from the global Phase III FRESCO-2 trial. Fruquintinib is already approved in the United States, Europe, and China.

TAK-906, a peripherally-restricted D2/D3 receptor antagonist, targets the stomach and vomiting center to treat gastroparesis, a condition with delayed gastric emptying causing nausea, vomiting, pain, and anorexia.

Takeda receives approval for FRUZAQLA (fruquintinib) in Japan for advanced or recurrent colorectal cancer, based on FRESCO-2 trial results showing consistent benefits and manageable safety profile.

S.K., D.A.M., J.P., H.S., X.Z., P.H., T.X., and H.S. have financial ties to various pharmaceutical companies, including stock ownership and advisory roles. F.C., J.D., E.V.C., H.S.W., T.Y., R.Y., and J.T. also report consulting or advisory roles and research funding from multiple institutions and companies.

Graft versus Host Disease Market to grow at 9.9% CAGR (2020-2034), driven by branded therapies, strong pipeline, and increased awareness. Market size in the US was $1 billion in 2023, expected to grow at 7.4% CAGR (2024-2034). Emerging therapies like Axatilimab and CSL964 to transform market. Key companies include Equillium, Biocon, Takeda, and CSL Behring.

The graft versus host disease market is growing due to the adoption of branded therapies like JAKAFI, IMBRUVICA, ORENCIA, and REZUROCK, a strong pipeline with over 10 new drugs expected to launch, and increased awareness of GvHD management. Innovative treatments and ongoing research aim to address unmet needs in this complex condition.