Japan Pharmaceutical News Flash

• September 12, 2018
• Read time: 2 minutes

On August 3, Japan's Pharmaceutical Affairs and Food Sanitation Council (Second Division) approved two new drugs for two cancer indications and five agents for seven indications. Drug approval is expected by September at the latest, and prices for new drugs will be added to the drug price registry in November of this year.

CDK4/6 inhibitor Abemaciclib (brand name: VERZENIO), approved for HER2-negative, unresectable or recurrent breast cancer patients. This is a CDK4/6 inhibitor. Compared to Ibrance, it is a second-line therapy. Its characteristic feature is that it is less likely to cause hematologic toxicity, but has stronger diarrhea as a side effect.

Bispecific antibody Blinatumomab approved for relapsed or refractory B-cell acute lymphoblastic leukemia. Also known as BiTE (Bispecific T-cell Engager), it links CD3 and CD19 to induce activation of cytotoxic T cells and thereby suppress tumor growth. Currently, this drug is in clinical trials for ALL (B-precursor acute lymphoblastic leukemia).

Third-generation EGFR-TKI Osimertinib (TAGRISSO), approved as first-line therapy for EGFR-positive, relapsed or unresectable non-small cell lung cancer patients.

OPDIVO indications expanded to three additional cancers, with one being usable in combination with YERVOY. The following three conditions are now covered. The dosing basis for YERVOY has changed from weight-based to a fixed dose of 240 mg per administration. Note that when combined with YERVOY, the initial dose is 80 mg.

1. Malignant pleural mesothelioma — the first immune drug approved for this condition. Clinical trials are currently being conducted for patients with malignant pleural mesothelioma not suitable for platinum drugs and pemetrexed.

2. Adjuvant therapy for melanoma patients after surgery — previously applicable only to unresectable or recurrent melanoma, now also applicable to post-surgical adjuvant therapy.

3. Unresectable or metastatic renal cell carcinoma — can be used in combination with OPDIVO and YERVOY.

Anti-CCR4 antibody Mogamulizumab — indication expanded. Previously limited to CCR4-positive cutaneous T-cell lymphoma, now applicable regardless of CCR4 positivity status.

AC220 (quizartinib), an FLT3 inhibitor designated for FLT3-mutant acute myeloid leukemia (rare disease drug).

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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Related Cancer Information

• Breast cancer
• Melanoma
• Lung cancer