FDA Approvals, News & Updates

Revlimid Approved for Patients with Follicular Lymphoma or Marginal-Zone Lymphoma

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - FDA Approvals, News & Updates, Lymphoma

On May 28, 2019, the FDA approved lenalidomide (Revlimid; Celgene), in combination with rituximab (Rituxan), for the treatment of patients with previously treated follicular lymphoma or marginal-zone lymphoma (MZL). The FDA used its priority review program for this approval, and granted lenalidomide plus rituximab an orphan drug designation for this new indication. [ Read More ]

Xpovio Receives FDA Approval for Patients with Relapsed or Refractory Multiple Myeloma

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - FDA Approvals, News & Updates, Multiple Myeloma

On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥4 previous therapies and did not respond to other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-­CD38 monoclonal antibody. The FDA reviewed selinexor using its fast track program, and granted it an orphan drug designation. [ Read More ]

Polivy FDA Approved for Patients with Relapsed or Refractory DLBCL

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - FDA Approvals, News & Updates, Lymphoma

On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations. [ Read More ]

Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer

Yvette Florio Lane

FDA Approvals, News & Updates, In the News

Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases. [ Read More ]

Yonsa (Fine-Particle Abiraterone Acetate) New Formulation Approved for Metastatic Prostate Cancer

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Prostate Cancer

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. [ Read More ]

Xospata (Gilteritinib) First Drug Approved as Monotherapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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%. [ Read More ]

Vizimpro (Dacomitinib) Approved for First-Line Treatment of Metastatic Non–Small-Cell Lung Cancer with EGFR Mutation

Loretta Fala

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lung Cancer

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%. [ Read More ]

Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for Solid Tumors Based on a Genetic Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates

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. [ Read More ]

Udenyca (Pegfilgrastim-cbqv) Second Biosimilar Approved to Reduce the Incidence of Infection Associated with Febrile Neutropenia

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates

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. [ Read More ]

Tibsovo (Ivosidenib) First Targeted Therapy Approved for Patients with Relapsed or Refractory Acute Myeloid Leukemia and IDH1 Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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%. [ Read More ]