FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Key Points

Heron Therapeutics, Inc, announced on August 10, 2016, that the U.S. Food and Drug Administration (FDA) has approved granisetron extended-release injection. Granisetron is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens.

Heron Therapeutics, Inc, announced on August 10, 2016, that the U.S. Food and Drug Administration (FDA) has approved granisetron (Sustol) extended-release injection. Granisetron is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens.

Granisetron is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s polymer-based drug delivery technology, Biochronomer, to maintain therapeutic levels of granisetron for ≥5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).

“Despite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control,” commented Ralph V. Boccia, MD, FACP, Medical Director, Center for Cancer and Blood Disorders. “In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less. [Granisetron], due to its extended-release profile, represents a novel option that can protect patients from CINV for a full 5 days.”

The granisetron global phase III development program was comprised of two, large, guideline-based clinical trials (NCT02106494, NCT00343460) that evaluated granisetron’s efficacy and safety in more than 2,000 patients with cancer. Granisetron’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (day 1 following chemotherapy) and the delayed phase (days 2–5 following chemotherapy).

“The [granisetron] clinical trial populations and results are highly representative of cancer patients in our real-world clinical practice,” said Jeffrey Vacirca, MD, FACP, Chief Executive Officer and Director of Clinical Research, North Shore Hematology Oncology Associates and Vice President, Community Oncology Alliance. “Use of moderately emetogenic chemotherapy regimens is widespread, and anthracycline/cyclophosphamide-based regimens are among the most commonly prescribed highly emetogenic chemotherapy regimens. The most significant challenge for my breast cancer patients receiving anthracycline/cyclophosphamide is CINV. [Granisetron] represents a better option to manage this devastating side effect of therapy.”

"We would like to thank the investigators, caregivers and most of all the patients who have helped us to achieve this important milestone,” commented Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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