FDA Approves Mobocertinib for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion

  • Mobocertinib gets accelerated approval for adult patients diagnosed with metastatic or locally advanced Non-Small Cell Lung Cancer with EGFR (epidermal growth factor receptor) Exon 20 Insertion.
  • Approval was based on the results of the Phase 1/2 trial that demonstrated approximately 1.5 years of median duration of response.

On September 15, 2021, the FDA (Food and Drug Administration) granted accelerated approval to Mobocertinib (sold under the brand name EXKIVITY by Takeda Pharmaceuticals, Inc.) for the treatment of patients suffering from metastatic or locally advanced Non-Small Cell Lung Cancer with EGFR (epidermal growth factor receptor) Exon 20 Insertion. The disease must have progressed during or post-treatment with platinum-based chemotherapy, as detected by an FDA-approved diagnostic test. 

Plus, the Oncomine Dx Target Test (Life Technologies Corporation) has also been recently approved by the US FDA for the selection of patients with the above-mentioned mutations and specifications for treatment with Mobocertinib.

Mobocertinib’s approval was granted on the basis of Study 101 of a multicohort, open-label, international, non-randomized clinical trial (NCT02716116) which involved a group of patients diagnosed with metastatic or locally advanced Non-Small Cell Lung Cancer with EGFR (epidermal growth factor receptor) Exon 20 Insertion. The efficacy of this drug was investigated in 114 patients whose cancer had progressed during or post-treatment with platinum-based chemotherapy. To be specific, the patients were administered a 160 mg oral dose of Mobocertinib daily until intolerable toxicity or disease progression. 

According to RECIST 1.1, ORR (overall response rate) and response duration were the main efficacy outcome measures. As per the reports, the median response duration was 17.5 months with an ORR of 28%. 

The common adverse reactions included nausea, diarrhea, stomatitis, vomiting, decreased appetite, fatigue, musculoskeletal pain, dry skin, paronychia, and rash. Moreover, 160 mg dose once daily is the recommended dosage of Mobocertinib (until intolerable toxicity or disease progression).

About EXKIVITY (Mobocertinib)

EXKIVITY is a small molecule oral drug (tyrosine kinase inhibitor) that is designed specifically to target the mutations of EGFR Exon20 insertion in patients with lung cancer. It is the first-in-class regimen to get FDA- approval for the treatment of patients with NSCLC with such a mutation as detected by an FDA-approved diagnostic test. 

View full prescribing information for EXKIVITY (Mobocertinib).

 

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