Drugs

FDA OKs Datroway for Triple-Negative Breast Cancer

FDA has approved Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy, expanding treatment options for patients with one of the most aggressive forms of breast cancer. The drug was previously approved for patients who have not previously received chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic disease.

The FDA action is based on results from the Phase 3 TROPION-Breast02 trial, which enrolled 644 patients with unresectable or metastatic TNBC. Patients were randomized to receive either datopotamab deruxtecan-dlnk or physician’s choice of chemotherapy, including paclitaxel, nab-paclitaxel, capecitabine, eribulin or carboplatin, an FDA release says.

Patients treated with datopotamab deruxtecan-dlnk achieved a median progression-free survival of 10.8 months, compared with 5.6 months for patients receiving chemotherapy. The treatment also demonstrated an overall survival benefit, with median overall survival of 23.7 months versus 18.7 months in the chemotherapy arm, FDA says. The confirmed overall response rate was 64% in the datopotamab deruxtecan-dlnk group, compared with 30% among patients treated with chemotherapy.

The prescribing information includes Boxed Warnings and Precautions for interstitial lung disease and pneumonitis, as well as warnings for ocular adverse reactions, stomatitis or oral mucositis, and embryo-fetal toxicity.

Datopotamab deruxtecan-dlnk is administered intravenously at a recommended dose of 6 mg/kg every three weeks until disease progression or unacceptable toxicity.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome