FDA approves treatment for two rare types of non-Hodgkin lymphoma
The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.
“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.”
Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. MF and SS are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. MF accounts for about half of all lymphomas arising from the skin. It causes itchy red rashes and skin lesions and can spread to other parts of the body. SS is a rare form of skin lymphoma that affects the blood and lymph nodes.
Poteligeo is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells.
FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.
“Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition,” said FDA Commissioner Scott Gottlieb, M.D. “The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo. This new generic drug application was also approved in its first cycle of review. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”
FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests
The U.S. Food and Drug Administration today alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman’s water has broken (also known as a rupture of the membranes containing amniotic fluid). A rupture of the membranes (ROM) can pose immediate and severe risks to the patient and developing fetus without proper patient management and timely intervention.
As part of the agency’s commitment to transparency in notifying the public about potential public health concerns, the FDA issued a Letter to Health Care Providers to remind providers that the labeling for these tests specifies that they should not be used on their own to independently diagnose a ROM in pregnant women. These tests have only been cleared for marketing by the FDA to be used by healthcare providers in conjunction with other clinical assessments to make critical patient management decisions regarding whether a ROM has occurred.
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