Biologics

Datroway sBLA for Triple-Negative Breast Cancer Under Review

AstraZeneca and Daiichi Sankyo’s antibody–drug conjugate Datroway (datopotamab deruxtecan) has been granted an FDA priority review as a potential first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for immunotherapy. Triple-negative breast cancer accounts for about 15% of all breast cancer cases and is associated with poorer outcomes than other subtypes.

The supplemental BLA has been given a user fee review action date in the second quarter.

If approved, Datroway would become the first therapy shown to significantly improve overall survival compared with chemotherapy in this first-line setting, where chemotherapy is currently the only approved option for most patients, according to the companies. About 70% of people with metastatic TNBC are not eligible for PD-1 or PD-L1 inhibitor therapy, either because their tumors do not express PD-L1 or due to other clinical or access-related factors.

The submission is supported by results from the Phase 3 TROPION-Breast02 trial, which compared Datroway with investigator’s choice of chemotherapy in previously untreated patients with locally recurrent inoperable or metastatic TNBC who could not receive immunotherapy. In the study, Datroway demonstrated a statistically significant five-month improvement in median overall survival versus chemotherapy, they say. The drug also reduced the risk of disease progression or death by 43%.

Additionally, the companies note that patients treated with Datroway experienced higher and more durable response rates than those receiving chemotherapy. The objective response rate was 62.5% with Datroway, compared with 29.3% for chemotherapy, and the median duration of response was 12.3 months versus 7.1 months, respectively. The safety profile observed in the trial was consistent with prior studies of Datroway in breast cancer.

Datroway is described as a TROP2-directed antibody–drug conjugate discovered by Daiichi Sankyo and co-developed and commercialized with AstraZeneca. It is already approved in more than 40 countries for certain patients with hormone receptor–positive, HER2-negative metastatic breast cancer, and is available in the U.S. under accelerated approval for previously treated EGFR-mutated non-small cell lung cancer.

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