The Lynx Group

FDA Approvals, News & Updates

Two human genes, BRCA1 and BRCA2 (BRCA1/2), produce proteins that block the growth of cancer, such as breast or ovarian cancer. These proteins ensure the stability of each cell’s genetic material and help to repair damaged DNA. A mutation in either BRCA results in these proteins not functioning correctly. Specifically, DNA damage may not be repaired effectively, which can lead to cancer.
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Acute myeloid leukemia (AML) is a rare but deadly cancer. In 2018, approximately 19,500 new cases of AML were estimated to be diagnosed in the United States and more than 10,600 people to die from the disease. Clinical trials data show that up to 70% of adults with AML have disease that completely responds to initial treatment with cytotoxic chemotherapy. However, the 3-year survival rate for patients with AML remains poor, at approximately 25%.
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Febrile neutropenia is a serious complication of cancer chemotherapy that can require treatment delays and chemotherapy dose reductions, which compromise the efficacy of treatment. Among patients with cancer who are receiving chemotherapy, approximately 1% have febrile neutropenia. This condition affects patient morbidity and mortality and its clinical management requires significant healthcare resources.
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Gene mutations or rearrangements in the tropomyosin receptor kinase (TRK) family of receptor tyrosine kinases are emerging as an important driver of cancer-cell growth in a wide range of cancers. Research has shown that neurotrophic receptor tyrosine kinase (NTRK) genes, which encode for TRK proteins, can fuse abnormally to other genes and enhance cell signals that support tumor growth. NTRK gene fusions are found in a variety of tumor types, including soft-tissue sarcoma, salivary gland cancer, infantile fibro­sarcoma, thyroid cancer, and lung cancer.
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Lung and bronchus cancer is the second most common form of cancer in the United States. In 2018, lung cancer was newly diagnosed in 234,030 individuals, representing 13.5% of all new cancer cases. Lung cancer remains the leading cause of cancer mortality in men and women, accounting for more than 25% of all cancer deaths, which translated to 154,050 deaths in 2018. The relative 5-year survival rate for metastatic lung cancer is only 4.7%.
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Acute myeloid leukemia (AML) is a rare but deadly hematologic cancer. In 2018, approximately 19,500 new cases of AML were diagnosed, and more than 10,600 people died from the disease in the United States. Although up to 70% of adults with AML have a complete response to initial treatment with cytotoxic chemotherapy, the responses are not durable. The 5-year survival rate for people with AML is only 24%.
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Prostate cancer is the third most common type of cancer in the United States, after breast cancer and lung cancer. In 2018 alone, 164,690 individuals were diagnosed with prostate cancer, accounting for nearly 10% of all new cancer cases, and 29,430 deaths were attributed to the disease. Prostate cancer is most frequently diagnosed in men aged 65 to 74 years (median age, 66 years). More than 98% of patients with prostate cancer survive ≥5 years; however, the 5-year survival rate drops to 30% for patients with metastatic disease.
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On April 12, 2019, the FDA accelerated the approval of erdafitinib (Balversa; Janssen), a fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with locally advanced or metastatic urothelial carcinoma and a susceptible FGFR3 or FGFR2 genetic alteration, as detected by an FDA-approved test, whose disease progressed after platinum-containing chemotherapy, making it the first targeted drug to receive approval for this patient population.
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On April 19, 2019, the FDA accelerated the approval of pembro­lizumab (Keytruda; Merck) plus ­axitinib (Inlyta; Pfizer) as first-line treatment of patients with advanced renal-cell carcinoma (RCC). Keytruda was previously approved as a single agent or in combination with other agents for many other indications and types of cancers.
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On May 2, 2019, the FDA approved ivosidenib (Tibsovo; Agios) for patients with newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years or those who have comorbidities that preclude the use of intensive induction chemotherapy. Ivosidenib was originally approved in 2018 for relapsed or refractory AML with IDH1 mutation.
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