SAN DIEGO--(BUSINESS WIRE)--Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on developing novel best-in-class treatments to address some of the biggest unmet patient needs, today announced the inclusion of SUSTOL® (granisetron) extended-release injection as part of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis Version 1.2017.
The NCCN has given SUSTOL a Category 1 recommendation, the highest level category of evidence and consensus, for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving HEC or MEC regimens. Importantly, the guidelines identify SUSTOL as a “preferred” agent for preventing CINV following MEC. Further, the guidelines highlight the unique, extended-release formulation of SUSTOL.
“Unfortunately, CINV remains an all too common reality associated with modern-day cancer treatment, and novel agents that can prevent or reduce the severity of this debilitating chemotherapy side effect have the potential to not only improve the quality of life of patients, but also enable patients to complete potentially life-saving treatment,” said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. “We greatly appreciate NCCN’s thorough evaluation of SUSTOL and recognition of the role it may play in improving cancer care.”
NCCN is a not-for-profit alliance that includes 27 of the world’s leading cancer institutions. The NCCN Guidelines document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes.
SUSTOL was approved by the U.S. Food and Drug Administration on August 9, 2016 for use in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of MEC or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. It is the first approved therapy that utilizes Heron’s Biochronomer® polymer-based drug delivery technology, allowing it to maintain therapeutic levels of granisetron for ≥5 days, covering both the acute and delayed phases of CINV.
Important Safety Information for SUSTOL
SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.
Injection site reactions (ISRs), including infection, bleeding, pain and tenderness, nodules, swelling, and induration, have occurred with SUSTOL. Monitor for ISRs following SUSTOL injection. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of SUSTOL.
Monitor for constipation and decreased bowel activity and consider optimizing patients’ current bowel regimens used for managing preexisting constipation. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur.
Hypersensitivity reactions have been reported and may occur up to 7 days or longer following SUSTOL administration and may have an extended course. If a reaction occurs, administer appropriate treatment and monitor until signs and symptoms resolve.
Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.
Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.
Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.
Please see accompanying Full Prescribing Information at www.SUSTOL.com
About Chemotherapy-Induced Nausea and Vomiting (CINV)
While chemotherapy is one of the most effective and common used therapies to help patients fight cancer, it is accompanied by debilitating side effects, including varying degrees of nausea and vomiting, often attributed as a leading cause of premature discontinuation of cancer treatment. Delayed nausea and vomiting, which occurs 2-5 days following chemotherapy treatment, is considered particularly debilitating for patients. The National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) have categorized chemotherapy regimens based on the degree to which they cause nausea and vomiting: low emetogenic chemotherapy (LEC), moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC).
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain. For more information, visit www.herontx.com.
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with the potential market opportunity for SUSTOL and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.