The Food and Drug Administration will review Dato-DXd for the treatment of certain patients with non-small cell lung cancer.
The Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for Dato-DXd (datopotamab deruxtecan) for the treatment of adults with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that received prior systemic therapy.
With the BLA granted, by the end of the year, this patient population may have a new treatment option that could improve outcomes over the current standard of care.
Pharmaceutical companies ask to file a BLA to the FDA, asking the agency for permission to introduce a therapy into the American market. Now, the FDA set a goal of making an approval decision for Dato-DXd in this patient population by the fourth quarter — so sometime between October to December — of 2024.
“[Dato-DXd] has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy. With regulatory discussions ongoing around the world and a parallel submission underway in the US in breast cancer, this is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, one of the manufacturers of the drug, said in a company-issued press release.
READ MORE:Dato-DXd Extends PFS in HR+/HER2- Inoperable or Metastatic Breast Cancer
The BLA is based on findings from the phase 3 TROPION-Lung01 clinical trial, in which Dato-DXd improved progression-free survival (time patients live before their disease worsens) compared to docetaxel, which is the current standard of care, in patients with locally advanced or metastatic NSCLC that was treated with at least one prior line of therapy. Specifically, according to data presented at the 2023 European Society for Medical Oncology Congress in October 2023, median progression-free survival was 4.4 months in the Dato-DXd group and 3.7 months in the docetaxel group.
Additionally, Dato-DXd reduced the risk of disease progression or death by 25% compared to docetaxel.
In the trial, Dato-DXd also led to a numerically higher improvement of overall survival (time until death of any cause) compared to docetaxel, though there was no statistically significant difference between the two groups, meaning that the researchers could not definitively decide if one treatment regimen outperformed the other when it came to this endpoint. Of note, the trial is ongoing and overall survival statistics will be assessed at the final analysis of the data, according to the press release.
Dato-DXd is also being studied in combination with Imfinzi (durvalumab) with or without carboplatin for the frontline treatment of advanced non-small cell lung cancer that is lacking genomic alterations, as well as other types of cancers.
Dato-DXd is a type of drug called an antibody drug conjugate that binds to a specific molecule found on cancer cells — in this case, TROP2 — and then delivers the cancer-killing substance directly to the cancer cells.
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“Today’s news is an important step forward in our goal of creating new standards of care that have the potential to transform the treatment of patients with non-small cell lung cancer. We are encouraged by the FDA’s acceptance of the BLA as we endeavor to make [Dato-DXd] in the first TROP2-directed antibody-drug conjugate approved to treat patients with nonsquamous non-small cell lung cancer after disease progression on prior systemic therapy. We look forward to working closely with the FDA to bring [Dato-DXd] to patients,” Dr. Ken Takeshita, global head of R&D at Daiichi Sankyo, the co-manufacturer of Dato-DXd said in the release.
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