medwireNews: The EMA has granted a series of positive opinions for marketing authorizations for the treatment of patients with HER2-positive breast cancer, RET-altered non-small-cell lung cancer (NSCLC), renal cell carcinoma, and urothelial carcinoma.
Breast cancer decisions
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for use of trastuzumab deruxtecan as a third- or later-line treatment for patients with unresectable or metastatic HER2-positive breast cancer.
The recommendation is given on the basis of the DESTINTY-Breast 01 trial findings demonstrating improved objective response rate and duration of response in this patient population.
The CHMP has also granted a conditional marketing authorization for the HER2 kinase inhibitor tucatinib in combination with trastuzumab and capecitabine as a third- or later-line treatment for HER2-positive locally advanced or metastatic breast cancer patients. The decision follows results from the HER2CLIMB trial and a similar US FDA approval for the agent.
Lung cancer decision
The RET receptor tyrosine kinase inhibitor selpercatinib has been granted a positive opinion for use in patients with RET fusion-positive advanced NSCLC, as well as those with medullary thyroid or thyroid cancer with RET alterations.
Selpercatinib may be given to NSCLC patients who require system treatment after receiving immunotherapy and/or platinum-based chemotherapy. The decision is based on findings from the LIBRETTO-001 trial and the agent was previously approved for these indications by the US FDA.
Genitourinary cancer decisions
The CHMP has recommended marketing authorization for use of a generic formulation of sunitinib (Sunitinib Accord). The multitargeted kinase inhibitor is indicated for advanced or metastatic renal cell carcinoma and several gastrointestinal tumor types.
Finally, avelumab has been granted a positive opinion for use as a first-line maintenance agent in locally advanced or metastatic urothelial carcinoma patients who have not progressed after platinum-based chemotherapy.
The EMA’s recommendation for the PD-L1 inhibitor is based on findings from the JAVELIN Bladder 100 trial and follows the FDA approval for avelumab in this indication.
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