Takeda Pharmaceutical Company Limited announced, the US FDA has given the authorization to EXKIVITY (mobocertinib) for the purpose of treating the adult patients with the metastatic non-small cell lung cancer (NSCLC). The EXKIVITY has been approved under the Accelerated Approval that has been based on the overall response rate, and the continued approval for the EXKIVITY might be contingent upon the description and verification of the trials
Teresa Bitetti, president of Global Oncology Business Unit at Takeda said, the approval of EXKIVITY has been responsible for introducing a new and effective option for the treatment of the patients with the EGFR Exon20 insertion along with NSCLC, that will be fulfilling the urgent need for this hard to cure cancer type.
Teresa Bitetti said, EXKIVITY has been the first and only oral therapy, which has been specifically designed for the purpose of targeting the EFGR Exon20 insertions, and they are now specifically encouraged by the duration of the responses that were observed with period of 1.5 years, and this approval has been responsible for reinforcing their commitment to meet the needs of the underserved population of the patients within the community of Oncology.
Simultaneously, the US FDA has also given the approval to the Oncomine Dx Target Test of Therma Fisher Scientific as an NGS companion diagnostics for the EXKIVITY for the purpose of identifying the NSCLC patients along with the EGFR Exon20 insertions, and the NGS Testing has been critical for the patients because it can enable more accurate diagnosis compared with the PCR testing.