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15-05-2020 | FDA | News


Selpercatinib receives FDA nod

Author: Shreeya Nanda


medwireNews: The US FDA has approved selpercatinib for the treatment of advanced lung and thyroid cancers with RET alterations.

The selective RET kinase inhibitor is indicated for adults with metastatic non-small-cell lung cancer, and individuals aged 12 years or older with locally advanced or metastatic medullary thyroid cancer or advanced RET fusion-positive thyroid cancer that is unresponsive to or ineligible for radioactive iodine therapy. The presence of RET alterations must be confirmed via laboratory testing before initiating treatment with selpercatinib.

The approval is based on three clinical trials that enrolled patients with one of the three tumor types and demonstrated overall response rates ranging from 64% to 100% following treatment with oral selpercatinib 160 mg twice a day.

Speaking to medwireNews, trial investigator Vivek Subbiah, from The University of Texas MD Anderson Cancer Center in Houston, USA said this decision “is an important milestone in personalized medicine and precision oncology for patients with RET-altered cancers.”

Noting that the approval has come within 3 years of the first patient’s enrollment in the first-in-human trial, he said that “[i]t demonstrates the utility of specific targeting of aberrantly activated oncogenes,” and is “a major win” for this patient population, one that “will inspire the development of more drugs for many rare cancers, which are an unmet need.”

Subbiah continued: “We thank all the motivated patients and their families who travelled long distances to enroll on this clinical trial. The US FDA approval opens up access to this life-saving drug for patients and their treating physicians.”

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group