Takeda Pharmaceutical Company Limited announced that the FDA has approved Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Exkivity is a first-in-class, oral tyrosine kinase inhibitor that was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation from the FDA. This agent is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. The manufacturer stated that continued approval for this indication may be dependent upon verification and description of clinical benefit in a confirmatory trial.
The FDA simultaneously approved Thermo Fisher Scientific's Oncomine Dx Target Test as a next-generation sequencing (NGS) companion diagnostic for Exkivity to identify NSCLC patients with EGFR Exon20 insertions. The manufacturer states that NGS testing is vital for these patients, as it can enable more accurate diagnoses compared with polymerase chain reaction (PCR) testing, which detects fewer than 50% of EGFR Exon20 insertions.
The FDA approval is based on overall response rate (ORR) and duration of response (DoR) results from a phase l/ll trial consisting of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated with the 160-mg dose.
Results from this trial were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from the phase l/ll trial and demonstrated a confirmed ORR of 28% per independent review committee (IRC) (35% per investigator) as well as a median DoR of 17.5 months per IRC, a median overall survival of 24 months, and a median progression-free survival of 7.3 months per IRC.
The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The Exkivity prescribing information includes a boxed warning for QTc prolongation and torsades de pointes and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.
Teresa Bitetti, president, Global Oncology Business Unit of Takeda, stated, "The approval of Exkivity introduces a new and effective treatment option for patients with EGFR Exon20 insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer. Exkivity is the first and only oral therapy specifically designed to target EGFR Exon20 insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years. This approval milestone reinforces our commitment to meeting the needs of underserved patient populations within the oncology community."
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