FDA Oncology Roundup for November 2013
Obinutuzumab (Gazyva) received FDA approval for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). The most common side effects observed in participants receiving obinutuzumab with chlorambucil were infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain, and fever. The drug is approved with a boxed warning regarding Hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.
FDA granted orphan drug designation to ADXS-HPV for the treatment of human papillomavirus (HPV)-associated head and neck cancer. Orphan drug designation is granted to a drug or biological product intended to treat a rare disease or condition. ADXS-HPV is an immunotherapy designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues.
Ibrutinib (Imbruvica) received FDA approval for the treatment of mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. Ibrutinib is intended for patients with MCL who have received at least one prior therapy. It works by inhibiting the enzyme needed by the cancer to multiply and spread. The most common side effects reported in participants were thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, edema, upper respiratory infection nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting, and decreased appetite.
Crizotinib (Xalkori) capsules were granted FDA regular approval for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The approval is based on demonstration of superior progression-free survival (PFS) and overall response rate for crizotinib-treated patients compared to chemotherapy in patients with ALK-positive NSCLC with disease progression after platinum-based doublet chemotherapy. Common adverse reactions in clinical trials with crizotinib included visual disorders, nausea, diarrhea, vomiting, constipation, edema, elevated transaminases, and fatigue.
FDA expanded the approved uses of sorafenib (Nexavar) to treat late-stage (metastatic) differentiated thyroid cancer. Sorafenib works by inhibiting multiple proteins in cancer cells, limiting cancer cell growth and division. The new use is intended for ptients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment.