FDA Approves TUKYSA® for Metastatic HER2-Positive Colorectal Cancer

Seagen Inc. announced FDA accelerated approval of TUKYSA for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer. It’s the first FDA-approved treatment for HER2-positive metastatic colorectal cancer. The FDA has granted accelerated approval for TUKYSA, based on its tumor response rate and durability of response from the phase 2 clinical trial MOUNTAINEER. TUKYSA had previously been granted Breakthrough Therapy Designation and Priority Review by the FDA.

Publish Date: 19-01-2023 Source: Seagen Inc.

Colorectal cancer (CRC) is the 3rd commonest cause of cancer death. Approximately 25% of patients have metastatic disease at diagnosis, and about 50%-60% of patients diagnosed with CRC further progressed to develop metastatic disease. Visceral obesity has been reported to adversely affect the prognosis of CRC in men. About a quarter of a contributor to genetic predisposition. The development time of CRC usually lasts from several to several years; therefore, diagnosing it early in developing the disease is essential. Previously diagnosed with cancer, a history of colon polyps, inflammatory bowel diseases, diabetes mellitus, or cholecystectomy may lead to colorectal cancer (CRC). Surgery is the primary form of treatment for colon cancer, whereas chemotherapy is typically used as an adjuvant. The 5-year overall survival for patients with localized, regional, and metastatic colon cancer is 91%, 72%, and 13%. Clinical outcomes in mCRC have improved significantly, mainly due to the identification of molecular subtypes. The median overall survival (OS) now approximates 30 months in clinical trial populations and two years in the general population. Molecular profiling of tumors is now routinely performed to identify the approximately 40% that are RAS wild type (WT) that are susceptible to anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody (mAB) therapy.

The incidence of colorectal cancer (CRC) in the USA ranges from 40 to 45 cases per million population.

However, the current Advanced and Metastatic Colorectal Cancer treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Irinotecan, Aflibercept, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Advanced and Metastatic Colorectal Cancer treatment. The key companies in the advanced development stage are Hoffmann-La Roche, Sanofi, etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Advanced and Metastatic Colorectal Cancer to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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