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Drug approvals in Japan | PMDA | MHLW Approvals | 2022 | 2023 | News | Media | Japan | iPharmaCenter

Updated: Dec 29, 2022

December 28, 2022

AstraZeneca's Calquence is approved for CLL naive patients in Japan.

AstraZeneca announced that Calquence (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor, was approved in Japan to treat chronic lymphocytic leukemia naive patients.

The approval was based on the ELEVATE-TN Phase III trial, in which the combination of Calquence plus obinutuzumab and Calquence monotherapy showed significant improvement in progression-free survival versus the chlorambucil and obinutuzumab combination.

At 24 months, progression-free survival was 93% with Calquence plus obinutuzumab, 87% with Calquence monotherapy, and 47% with obinutuzumab and chlorambucil combination.

Calquence was previously approved for relapsed or refractory chronic lymphocytic leukemia patients.

Also read: Japan Healthcare System


December 23, 2022

Libtayo was approved for advanced or recurrent cervical cancer.

The Ministry of Health, Labor, and Welfare (MHLW) approved Libtayo (cemiplimab) for treating advanced or recurrent cervical cancer patients whose cancer progressed following chemotherapy.

The approval was based on the Phase 3 EMPOWER-Cervical 1 trial, which enrolled 608 patients across 14 countries, irrespective of PD-L1 status. In the trial, Libtayo was compared with the physician's choice of chemotherapy. The study was stopped early as Libtayo showed significant improvement in overall survival among squamous cell carcinoma patients.

Also read: Top 10 pharmaceutical companies

Libtayo was approved in November 2022 by European Commission for treating adult patients with recurrent or metastatic cervical cancer whose disease progressed after chemotherapy.

Also read: China drug approvals


December 22, 2022

Yescarta was approved in