medwireNews : The US FDA has approved elacestrant  for advanced breast cancer and also allowed the adjuvant use of pembrolizumab  for resectable non-small-cell lung cancer (NSCLC).

medwireNews : The US FDA has authorized  the use of durvalumab plus tremelimumab alongside first-line platinum-based chemotherapy in the metastatic non-small-cell lung cancer (NSCLC) setting.

medwireNews : The US FDA has approved fam-trastuzumab deruxtecan-nxki (T-DXd) for the treatment of HER2-low breast cancer and also for HER2 -mutant non-small-cell lung cancer (NSCLC).

US FDA immunotherapy approval led to a significant increase in use, but did not eliminate socioeconomic disparities among users that were apparent prior to approval, study findings indicate.

Suitable patients are to be identified using the companion VENTANA PD-L1 (SP263) diagnostic assay (Ventana Medical Systems, Inc, Oro Valley, Arizona, USA), simultaneously approved by the FDA.

The FDA also approved a companion diagnostic assay – namely Ki-67 IHC MIB-1 pharmDx (Agilent, Inc, Santa Clara, California, USA) – to identify patients who can receive abemaciclib.

medwireNews: Following accelerated approval by the US FDA, mobocertinib can now be used in previously treated patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations.

medwireNews: Patients with urothelial carcinoma who have a high risk for recurrence following radical resection may be given nivolumab in the adjuvant setting, the US FDA has announced .

Read more on this US FDA announcement here

medwireNews : The US FDA has approved the combination of lenvatinib and pembrolizumab for treatment-naïve adult patients with advanced renal cell carcinoma (RCC).

medwireNews: Patients with high-risk, early-stage triple-negative breast cancer (TNBC) may be given pembrolizumab with neoadjuvant chemotherapy and then as monotherapy following surgery, the US FDA has announced .

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

The FDA also approved the Guardant360® CDx assay (Guardant Health Inc, Redwood City, California, USA) as a companion diagnostic test to detect the insertions.

medwireNews: Sacituzumab govitecan has been given accelerated approval from the US FDA for previously treated locally advanced or metastatic urothelial cancer.

medwireNews : Cemiplimab may be given as a first-line therapy for locally advanced non-small-cell lung cancer (NSCLC) patients who have high PD-L1 expression, the US FDA says .

medwireNews : The US FDA has approved  the use of nivolumab plus cabozantinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

medwireNews : The US FDA has issued positive decisions for the use of margetuximab-cmkb in breast cancer, adjuvant osimertinib in lung cancer, and relugolix in prostate cancer.

medwireNews : The US FDA has permitted the use of 68 gallium-labeled prostate-specific membrane antigen (68Ga-PSMA-11) as a tracer for positron emission tomography (PET) to detect prostate cancer metastases or recurrence.

medwireNews : The US FDA has approved nivolumab plus ipilimumab as a first-line treatment for unresectable malignant pleural mesothelioma.