Drugs

Comments on Draft PD Cancer Treatment Guidance

Genentech says it commends FDA for leveraging scientific and regulatory experience to develop guidance for sponsors on how PK-based criteria can be used to support registration of alternative dosing regimens beyond those studied in dedicated clinical trials. Responding to an agency draft guidance, Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer, Genentech says it believes that the implementation of PK-based and other MIDD (model-informed drug development) approaches are critical to efficiently develop patient-centric treatment options that minimize risk and burden to patients while preserving the necessary data for doctors and patients to make informed decisions that fit the needs of individual patients.

The letter urges FDA to expand the guidance to other antibody-based therapies. “While we recognize that PD-1/L1 blocking antibodies are relatively well understood,” the company says, “we note that there are many antibody-based therapies with wide therapeutic windows for which the proposed PK-based criteria is highly relevant….”

In its comment, AbbVie says the guidance can apply to other class agents with similar antagonist activity and mechanism of action.

Janssen provides general comments on combination regimens, alternative routes of administration, and reference dosing regimen, and specific line-by-line comments.

The GlaxoSmithKline response suggests adding clarifying text on two issues and gives line-by-line comments.

Finally, Pfizer submits specific line-by-line comments.

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