(Thyroid Cancer) Is Retevmo Effective?

Retevmo Approved in Japan for RET-Positive Thyroid Cancer

On February 25, 2022, Eli Lilly Japan announced that the antineoplastic drug Retevmo (selpercatinib) Capsules 40mg and 80mg received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for two indications:

• RET fusion gene mutation-positive, unresectable thyroid cancer
• RET gene mutation-positive, unresectable medullary thyroid cancer

This is the first drug in Japan to be approved for both patient populations.

Basis for Approval: LIBRETTO-001 Phase 1/2 Trial

The approval is based on the international LIBRETTO-001 Phase 1/2 trial, which evaluated selpercatinib 160 mg orally twice daily in:

1. Patients with RET fusion-positive unresectable thyroid cancer with prior chemotherapy (N=10)
2. Patients with RET fusion-positive unresectable thyroid cancer without prior chemotherapy (N=12)
3. Patients with RET mutation-positive unresectable medullary thyroid cancer with prior chemotherapy (N=97)
4. Patients with RET mutation-positive unresectable medullary thyroid cancer without prior chemotherapy (N=90)

Response rates:

1. 50.0%
2. 100%
3. 68.0%
4. 63.3%

Safety — most common adverse events:

• Dry mouth: 35.3%
• Hypertension: 31.8%
• ALT elevation: 28.0%
• AST elevation: 26.8%
• Fatigue: 25.3%

Eli Lilly Japan's Head of Oncology Medical Affairs stated: "Following last year's approval of Retevmo for non-small cell lung cancer providing patients with a new treatment option, this approval for both RET fusion-positive and RET mutation-positive unresectable thyroid cancers represents another milestone. Eli Lilly Japan will focus on ensuring appropriate use to help each patient."

Source: https://news.lilly.co.jp/PDFFiles/2022/22-05%20co.jp.pdf

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

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