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Takeda’s EXKIVITY Gets FDA Greenlight For Non-Small Cell Lung Cancer

Osaka-based pharma, Takeda Pharmaceutical Company Limited (“Takeda”) on Wednesday announced the U.S. Food and Drug Administration (FDA)’s approval of 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) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has advanced on or after platinum-based chemotherapy. EXKIVITY, which received priority review and had FDA’s Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation is the first and only approved oral therapy expressly aimed at EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval on the ground of overall response rate (ORR) and DoR. Continued approval for this indication may depend on verification and description of clinical advantages in a confirmatory trial.

“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,” disclosed Teresa Bitettti, president, Global Oncology Business Unit, Takeda. “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.”

Similarly, The FDA announced the approval of Thermo Fisher Scientific’s Oncomine Dx Target Test as an NGS companion diagnostic for EXKIVITY to identify NSCLC patients with EGFR Exon20 insertions. NGS testing is very important for these patients, as it can ensure more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which picks up less than 50% of EGFR Exon20 insertions.

“EGFR Exon20 insertion + NSCLC is an underserved cancer that we have been unable to target effectively with tradition EGFR TKIs,” noted Pasi A. Janne, MD, PhD, Dana Farber Cancer Institute. “The approval of EXKIVITY (mobocertinib) earmarks another major step forward that offers physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses.”

"Patients with EGFR Exon20 insertion + NSCLC have historically faced a unique set of challenges living with a very rare lung cancer that is not only underdiagnosed but also lacking targeted treatment options that can improve response rates," said Marcia Horn, executive director, Exon20 Group at ICAN, International Cancer Advocacy Network. "As a patient advocate working with EGFR Exon20 insertion+ NSCLC patients and their families every day for nearly five years, I am thrilled to witness continued progress in the fight against this devastating disease and I am grateful for the patients, families, healthcare professionals and scientists across the globe who contributed to the approval of this promising targeted therapy."