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Exkivity FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 6, 2023.

FDA Approved: Yes (Discontinued) (First approved September 15, 2021)
Brand name: Exkivity
Generic name: mobocertinib
Dosage form: Capsules
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non-Small Cell Lung Cancer

Exkivity (mobocertinib) is an oral tyrosine kinase inhibitor for the treatment of patients with epidermal growth factor receptor (EGFR) exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC).

Development timeline for Exkivity

Oct  2, 2023Takeda Provides Update on Voluntary Withdrawal Exkivity┬« (mobocertinib)
Sep 15, 2021Approval FDA Approves Exkivity (mobocertinib) for EGFR Exon20 Insertion+ Non-Small Cell Lung Cancer (NSCLC)
Apr 27, 2021Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

Further information

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