Drugs

FDA Backs Jaguar on Cancer Diarrhea Drug Development

Jaguar Health says it is planning to conduct a pivotal trial of crofelemer for cancer therapy-related diarrhea (CTD) in breast cancer patients. A recent Type C meeting with FDA led to agreement on the trial after the agency reviewed data from the company’s OnTarget trial, which did not meet its primary endpoint across all cancer types. The company says it provided the agency with a subgroup analysis showing a statistically significant benefit in the breast cancer subgroup, which Jaguar says will now be the focused patient population.

Of the 287 total trial participants, 183 were breast cancer patients that showed a significantly greater proportion of “monthly responders” — patients reporting improvements in diarrhea — compared to placebo.

Jaguar says the agency meeting included patient advocates who experienced significant relief from crofelemer. In addition to the breast cancer study, the meeting supported the company’s decision to launch an expanded access program for patients who may not qualify for the trial, including those in adjuvant and neoadjuvant treatment settings, according to the company.

Jaguar believes this patient population may qualify for orphan drug designation, which would make the company eligible for tax credits, waived FDA fees, and seven years of market exclusivity if crofelemer is approved. In addition, Jaguar intends to apply for Breakthrough Therapy and Fast Track designations to expedite development and review.

Crofelemer is derived from the red bark sap of the Croton lechleri tree, found in the Amazon rainforest.

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