Datopotamab Deruxtecan

A targeted cancer therapy from AstraZeneca’s alliance with Daiichi Sankyo is now FDA approved to treat certain cases of advanced breast cancer, giving the British pharmaceutical giant another product to fill out an oncology portfolio that’s a key part of its revenue growth strategy. The regulatory decision announced late Friday covers the treatment of adults with advanced cases of breast cancer that is HR positive and HER2 negative and cannot be removed by surgery. Also, these cancers must have advanced or spread following treatment with an endocrine-based therapy and chemotherapy. The drug, known in development as datopotamab deruxtecan, or Dato-DXd, will be marketed under the brand name Datroway. Datroway is part of a class of therapies called antibody drug conjugates (ADCs), which are made by linking a toxic chemotherapy payload to a targeting antibody. The target of Datroway is TROP2, a protein abundant on the surface of many types of cancer cells, including breast cancer cells. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech The AstraZeneca/Daiichi Sankyo drug was evaluated in an open-label Phase 3 study that enrolled 732 patients with advanced breast cancer. Study participants were randomly assigned to receive the study drug or chemotherapy. The main goals were measuring progression-free survival and overall survival. Results showed median progression-free survival of 6.9 months in the Datroway arm compared with 4.9 months in the chemotherapy arm, which was enough to be statistically significant. But Datroway fell short of statistical significance on the measure of overall survival, with a median 18.6 months in the study drug arm compared with 18.3 months for those treated with chemo. AstraZeneca already markets an ADC for breast cancer. Enhertu was initially approved in 2019 as a treatment for HER2-positive breast cancer. The ADC’s approval later expanded to include HER2-low metastatic breast cancer and HER2-positive non-small cell lung cancer. Last year, the FDA approved Enhertu for treating solid tumors regardless of where they’re found in the body as long as they express HER2. AstraZeneca has set a goal bringing to market at least 20 new drugs by 2030, growing annual revenue to $80 billion. The company said Datroway is now the eighth new medicine for its 2030 goal. “With this first approval of Datroway in the U.S., we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers,” Dave Fredrickson, executive vice president, oncology hematology business unit, AstraZeneca, said in a prepared statement. Biopharma information services firm Citeline included Datroway in its report on key potential drug launches for 2025. The drug’s Phase 3 results are comparable to those of Trodelvy, a TROP2-targeting ADC marketed by Gilead Sciences as a second-line treatment for HR positive, HER2 negative breast cancer, the report said. But Datroway’s results come up short compared with Enhertu. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient The Citeline report also noted one treatment-related death in the Datroway trial. Given that patients with advanced breast cancer have other treatment options, the potential safety risks could place the drug lower on a physicians’ lists of available therapies, Citeline said. For those reasons, Datroway is unlikely to stand out as a leader in this setting and is expected to get a small piece of market share, the report said. AstraZeneca said Datroway submissions in breast cancer are still under regulatory review in Europe and China, among other markets. The company is also seeking to expand use of the drug to other cancers. Last week, the FDA accepted an application seeking approval of the ADC for EGFR-mutated non-small cell lung cancer. A regulatory decision in this indication is expected in the third quarter of this year. Public domain image by the National Cancer Institute

AstraZeneca (AZ) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) has been approved by the US Food and Drug Administration (FDA) to treat a subset of breast cancer patients. The TROP2-targeting antibody drug conjugate (ADC) has been authorised for use in adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy. The FDA’s decision was based on positive results from the late-stage TROPION-Breast01 trial, in which intravenous Datroway reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy. The safety profile of Datroway was also shown to be consistent with the known profile of the drug, with no new safety concerns identified. More than 300,000 people are diagnosed with breast cancer in the US every year, and HR-positive, HER2-negative breast cancer accounts for approximately 70% of cases. Endocrine therapies, which work by either lowering the amount of hormones in the body or blocking them from getting to breast cancer cells, are widely given in the early lines of treatment for those with HR-positive metastatic disease. However, further efficacy from endocrine therapy is often limited following initial treatment, and the current standard of care at this point is chemotherapy, which is associated with poor response rates and outcomes. Datroway belongs to a relatively new class of cancer drugs that combine the selectivity of antibodies with the potent cell-killing power of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones. Additional regulatory submissions for Datroway in breast cancer are under review in the EU, China and other markets, the companies said. Global principal investigator for TROPION-Breast01 Aditya Bardia, UCLA Health Jonsson Comprehensive Cancer Center, said: “Despite considerable progress in the HR-positive, HER2-negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy. “The approval of [Datroway], a novel TROP2-directed ADC, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy.”