Drugs

ODAC Sees Value in Withdrawn Pfizer Drug

The Oncologic Drugs Advisory Committee voted 6-1 on 7/11 to recommend to FDA that Pfizer’s Mylotarg (gemtuzumab ozogamicin) 3 mg/m²in combination with chemotherapy has a favorable risk/benefit profile for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML). Mylotarg was originally approved under FDA’s accelerated approval program in 2000 for use as a single agent in patients with CD33-positive AML who had experienced their first relapse and were age 60 or older. The drug was voluntarily withdrawn by Pfizer in 2010 after a confirmatory Phase 3 trial did not show a clinical benefit for its use as a single agent in patients with CD33-positive AML, and the rate of fatalities as a result of treatment-related toxicity was significantly higher in the Mylotarg arm of the trial.

Committee discussions were based on a BLA currently under agency review. Pfizer says it is seeking approval for two U.S. indications: in combination with standard chemotherapy for treating previously untreated de novo CD33-positive AML, and as monotherapy for treating CD33-positive AML patients in first relapse who are age 60 or older and who are not considered candidates for other cytotoxic chemotherapy.

Mylotarg is described as an investigational antibody-drug conjugate comprising the cytotoxic agent calicheamicin, attached to a monoclonal antibody targeting CD33, an antigen expressed on the surface of myeloblasts in more than 90% of AML patients. Pfizer says that when Mylotarg binds to the CD33 antigen on the cell surface, it is absorbed into the cell and calicheamicin is released, causing cell death.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome