Drugs

Dose Optimization Info for Combo Drugs Needed: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says a recent FDA draft guidance on oncologic drug development provides limited information on how to optimize the dosage for oncology products that are developed for use in combination with other oncology therapies. In comments to FDA on its draft “Optimizing the Dosage of Human Prescription Drugs and Biological Products for Treatment of Oncologic Diseases,” PhRMA encourages the agency to “explicitly note in the final guidance that FDA will take a case‐by‐case approach when evaluating dosage optimization for combinations.

The drug lobbying group also took issue with the guidance’s discussion on the historic use of dose-finding trials to determine the maximum tolerated dose (MTD). It says the document highlights the “risk of unnecessary toxicities using the MTD approach but does not emphasize the potential risk of exposing patients with life-threatening disease to a sub‐therapeutic dosage and lower efficacy in instances where the MTD or maximum administered dose (MAD) may be the only biologically active dose or in instances where observed non‐clinical pharmacodynamic data is the main basis for requests to evaluate lower dosage(s),” it says. PhRMA requests that the FDA further elaborate on how sponsors can “minimize the risk of underdosing patients, particularly in expansion cohorts, while continuing to assess optimal dosage.”

Additionally, PhRMA pointed out that antibody‐drug conjugates (ADCs) require a hybrid approach to dose optimization. “The dose‐response relationships for these oncologic products could be different from other modalities described in the current draft guidance and in some cases, efficacy may be correlated with toxicity,” the group’s comments say. It suggests that FDA include considerations for dosage optimization of ADCs in the final guidance.

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