FDA Approves Relugolix for Advanced Prostate Cancer

Relugolix (OrgovyxTM, Myovant Sciences) has been FDA approved for the treatment of patients with advanced prostate cancer. A gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix is the first oral hormone therapy to be approved for this disease. The approval was based on the phase 3 HERO trial (NCT03085095). "Relugolix was developed as an oral, highly selective, GnRH antagonist that is given once daily with an effective half-life of 25 hours," write the investigators in their June...
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Tirbanibulin FDA Approved for Actinic Keratosis

The FDA has now approved tirbanibulin (Klisyri®, Athenex) for treating actinic keratosis (AK) on the face or scalp topically. Actinic keratosis is a precancerous lesion that forms on skin that has been damaged by long-term, chronic exposure to ultraviolet rays from the sun and/or indoor tanning. As the second most common diagnosis made by dermatologists in the US, AK will develop into skin cancers 10%-15% of the time when left untreated. Approval was based on effective results shown in two pivot...
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Jaume Mora, MD, PhD: Naxitamab Approval for High-Risk Neuroblastoma in the Bone or Bone Marrow

Recently, the FDA approved naxitamab in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow. In this interview, Jaume Mora, MD, PhD, Scientific Director of Oncology and Hematology at Sant Joan de Déu Barcelona Children's Hospital and lead investigator of one of the trials on which the approval was based, speaks with i3 Health about the benefits of naxitamab for patients with relapsed/r...
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FDA Approves Gallium 68 PSMA-11 for PET Imaging in Prostate Cancer

The FDA has approved gallium (Ga) 68 PSMA-11, a radioactive diagnostic agent, for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in patients with prostate cancer. Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis who are eligible for surgery or radiation therapy and for patients who have suspected recurrence based on elevated levels of prostate-specific antigen (PSA). The first drug to be approved specifica...
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Pembrolizumab FDA Approved for Triple-Negative Breast Cancer

The FDA recently approved pembrolizumab (Keytruda®, Merck & Co) with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) for those whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. In addition, the FDA approved the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.), to select patients with TNBC for pembrolizumab. Efficacy was shown in KEYNOTE-355 (NCT02819518), a multicenter, double-bl...
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