On September 13, 2016, the FDA modified the dosage regimen of nivolumab (Opdivo) for the treatment of patients with renal-cell carcinoma, metastatic melanoma, and non–small-cell lung cancer (NSCLC) to 240 mg intravenously (IV) every 2 weeks.
This approved modification adjusts the drug's labeling by replacing the single-dose regimen of nivolumab (ie, 3 mg/kg IV every 2 weeks) with the new regimen for use until disease progression or intolerable toxicity occurs.
Notably, the dosing regimen for nivolumab in combination with ipilimumab for the treatment of patients with melanoma will remain unchanged.
However, after completing ipilimumab therapy, it is recommended that the patient be given nivolumab 240 mg every 2 weeks until disease progression or intolerable toxicity occurs. The recommended dose of nivolumab for patients with classical Hodgkin lymphoma remains 3 mg/kg IV every 2 weeks until disease progression or intolerable toxicity occurs.
The FDA's approval of this regimen modification was based on population pharmacokinetics analyses, and on dose- and exposure-response analyses comparing the pharmacokinetics exposure, safety, and efficacy of the proposed new dosing regimen with the previously approved regimen.
Using simulations from the population pharmacokinetics model, the FDA determined that the overall exposure with nivolumab 240 mg every 2 weeks was similar to that of nivolumab
3 mg/kg every 2 weeks. The <6% difference in exposure is not likely to have a clinically meaningful effect on safety and efficacy, because dose- and exposure-response relationships appear to be moderately flat in patients with renal-cell carcinoma, metastatic melanoma, and NSCLC.
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On September 7, 2016, the FDA recommended against the use of ovarian cancer screening tests and alerted women to the associated risks of using them. The FDA cited particular concern for the delay in providing effective preventive care to women who are asymptomatic but are still at increased risk for ovarian cancer.
Although screening tests for breast, colon, and cervical cancers are effective for early detection and for prevention of cancer-related deaths, no valid data support the use of any test, including those approved by the FDA for other uses, as a screening tool for ovarian cancer.
Tests currently marketed as ovarian cancer screening tests have not demonstrated accuracy or reliability in screening asymptomatic women for early ovarian cancer, according to available data from clinical trials, professional healthcare society recommendations, and the US Preventive Services Task Force.
Because the use of unverified ovarian cancer screening tests may be harmful for women who are at increased risk for ovarian cancer (eg, neglecting to take appropriate actions to reduce their future risk because test results demonstrate that no cancer is currently present), the FDA advises that such tests should not be used by women at increased risk for ovarian cancer.
The FDA recommends that women (including those with an increased risk for ovarian cancer) not depend on ovarian cancer screening test results when making treatment decisions; discuss ways for reducing their risk for ovarian cancer with their physician (especially if they have a family history of the disease or have the BRCA1 or BRCA2 mutations); and note that there are currently no safe and effective ovarian cancer screening tests available.
