The EMA has endorsed the adoption of a new indication for cemiplimab, to treat patients with PD-L1-positive advanced NSCLC in combination with

medwireNews : The EMA has recommended granting a marketing authorization  for Akeega (Janssen-Cilag International NV, Beerse, Belgium), a fixed-dose combination of niraparib and abiraterone acetate, for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

medwireNews : The EMA has recommended that the indication for darolutamide be expanded to include the treatment of metastatic hormone-sensitive prostate cancer (HSPC).

The EMA has adopted a positive opinion for the first-line use of olaparib in men with metastatic castration-resistant prostate cancer.

medwireNews : The EMA has recommended changes to the indications for the PARP inhibitor olaparib and the antibody–drug conjugate trastuzumab deruxtecan in breast cancer.

The EMA supports extending the indication of abemaciclib to include adjuvant therapy of high-risk early breast cancer.

medwireNews : The EMA recommends expanding the indication for nivolumab monotherapy  to include the adjuvant treatment of PD-L1-positive, high-risk muscle-invasive urothelial carcinoma (MIUC).

medwireNews: The EMA has recommended approval  of relugolix for the treatment of advanced hormone-sensitive prostate cancer.

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medwireNews : The EMA has adopted a positive opinion for enfortumab vedotin in urothelial cancer and for pembrolizumab in the adjuvant renal cell carcinoma (RCC) setting .

approvalsWatch: The EMA has adopted a positive opinion recommending approval of sotorasib for the treatment of KRAS G12C-mutated NSCLC harboring a

medwireNews: The EMA has adopted a positive opinion  for the use of sacituzumab govitecan in previously treated patients with unresectable or metastatic triple-negative breast cancer (TNBC).

approvalsWatch: Amivantamab has received a positive opinion from the EMA for use in NSCLC patients with a EGFR exon 20 insertion mutation after

approvalsWatch: The EMA has recommended expanding the indication of pembrolizumab to include PD-L1-high advanced triple-negative breast cancer.

medwireNews: The EMA has recommended granting a conditional marketing authorization to pralsetinib for use in patients with RET fusion-positive non-small-cell lung cancer (NSCLC) who are RET inhibitor-naïve.

approvalsWatch: Lenvatinib plus pembrolizumab has been given the go-ahead by the EMA for the first-line treatment of advanced renal cell carcinoma.

medwireNews : The EMA recommends adopting a new indication for osimertinib as adjuvant therapy for resectable early-stage non-small-cell lung cancer (NSCLC).

The EMA has adopted a positive opinion for the first-line use of cemiplimab in patients with NSCLC and high PD-L1 expression.

medwireNews: The EMA has adopted a positive opinion for the use of nivolumab  in combination with ipilimumab  for the first-line treatment of adult patients with inoperable malignant pleural mesothelioma.

medwireNews : Cabozantinib plus nivolumab has been given the EMA go-ahead  as a first-line treatment for European patients with advanced renal cell carcinoma (RCC).