FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

Coverage, in order

1. 5d ago
   first FDA Drug Safety / Drugs feed indie

   FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

   On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with RET-altered metastatic thyroid cancer or solic tumors.

2. 2d ago
   FDA Drug Safety / Drugs feed indie

   FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

   FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

3. 2d ago
   FDA Drug Safety / Drugs feed indie

   FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

   On April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory

4. 2d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

   FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

5. 2d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves selpercatinib for medullary thyroid cancer with a RET mutation

   On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test.

6. 2d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves selpercatinib for RET fusion-positive thyroid cancer

   On June 12, 2024, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.

7. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer

   On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) br

8. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves cabozantinib for differentiated thyroid cancer

   FDA approved cabozantinib (Cabometyx, Exelixis, Inc.) for patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.

9. 1d ago
   FDA Drug Safety / Drugs feed indie

   FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

   On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

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