News Flash 3.2023
At the beginning of March, the Food and Drug Administration (FDA) approved treatment of Abemaciclib (Verzenio) for two years, combined with hormonal therapy, for early stage breast cancer patients with hormone receptor-positive HER2-negative tumors who underwent surgery and are at high risk of recurrence (i.e. either ≥4 axillary lymph node involvement, or 1-3 axillary lymph […]
News Flash 2.2023
At the beginning of February, the Food and Drug Administration (FDA) approved Sacituzumab govitecan (Trodelvy) for breast cancer patients with unresectable locally advanced or metastatic disease, whose tumors are hormone receptor-positive HER2-negative, and who have been treated with both endocrine therapy and chemotherapy*. Trodelvy is a targeted (biological) therapy called an anti-drug conjugate. It is […]
News Flash 1.2023 (2)
Several weeks ago, the Food and Drug Administration approved Zanubrutinib (Brukinsa) for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Brukinsa is a type of targeted therapy. It works by blocking the uncontrolled growth of cancer cells and so helps to stop their spread. The approval was based on […]
News Flash 1.2023 (1)
Recently, the Food and Drug Administration approved Keytruda (Pembrolizumab) – an immunotherapy drug that helps the immune system to fight cancer cells – combined with adjuvant chemotherapy, for the treatment of patients with non-small cell lung cancer whose tumors were completely resected. The approval refers to early stage non-small cell lung cancer patients who did […]
News Flash 12.2022
In the middle of December, the Food and Drug Administration approved Adstiladrin (Nadofaragene firadenovec) for patients with unresponsive high-risk early stage bladder cancer. Adstiladrin is a gene therapy drug. Gene therapy is a new generation of medicine that uses genes to treat, prevent or cure medical disorders. The approval of Adstiladrin was based on […]
News Flash 11.2022
At the beginning of November, the Food and Drug Administration approved Tremelimumab (an immunotherapy drug that helps the immune system to fight cancer cells) combined with Durvalumab (another immunotherapy drug) and chemotherapy, for the treatment of patients with metastatic non-small cell lung cancer who are not candidates for biological treatment and have not received prior […]
News Flash 10.2022
Recently, the Food and Drug Administration approved Tremelimumab (an immunotherapy drug that helps the immune system to fight cancer cells) combined with Durvalumab (another immunotherapy drug) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). The approval was based on results from a clinical trial in which 782 patients with unresectable HCC were enrolled. […]
News Flash 8.2022 (2)
Recently, the Food and Drug Administration approved Darolutamide (Nubeqa) tablets in combination with chemotherapy, for patients with metastatic prostate cancer whose tumors are hormone-sensitive. Darolutamide (given as tablets) is a type of hormone therapy. Hormone therapy is a common treatment for prostate cancer. The goal of this treatment is to reduce levels of male hormones, […]
News Flash 8.2022 (1)
At the beginning of August, the Food and Drug Administration approved Trastuzumab Deruxtecan (Enhertu) for HER2-low breast cancer patients with unresectable tumors who developed recurrence within a short time of completing adjuvant chemotherapy, as well as for HER2-low breast cancer patients with metastatic disease who have received prior chemotherapy. The HER2 protein regulates and controls the […]
News Flash 6.2022
Recently, the Food and Drug Administration approved Nivolumab (Opdivo) – an immunotherapy drug – for first line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma. Opdivo should be given in combination with chemotherapy, or in combination with Ipilimumab (another immunotherapy drug). The approval is supported by results from a clinical trial in […]