Adverse Effects

Data from the phase 3 ROMAN trial and the phase 2b GT-201 trial support the new drug application for avasopasem in radiotherapy-induced severe oral mucositis for those with head and neck cancer.

A medical oncologist and research audiologist from St. Jude Children’s Research Hospital discuss how sodium thiosulfate injection may improve quality of life by preventing cisplatin-associated ototoxicities in pediatric patients with localized non-metastatic tumors, although more research is needed.

The new drug application for avasopasem for radiotherapy-induced severe oral mucositis in patients with head and neck cancer is supported by findings from the phase 3 ROMAN trial and phase 2b GT-201 trial.

Findings from a meta-analysis highlighted an association between risk of cutaneous adverse effects and use of PI3K inhibitors across different types of cancer.

Initial findings from a phase 2 trial showed trilaciclib given before sacituzumab govitecan-hziy lessened the severity of adverse effects in patients with unresectable locally advanced or metastatic triple-negative breast cancer.

Across various cancer types, stereotactic ablative body radiotherapy was found to be a safe method for treating oligometastes.

Sodium thiosulfate, which appears to be effective in decreasing the risk for hearing loss related to treatment with cisplatin, received FDA approval in pediatric patients with localized, non-metastatic solid tumors.

Based on evidence from the phase 3 ADVANCE and RECOVER trials, the FDA has approved eflapegrastim-xnst injection to decrease the incidence of infection related to febrile neutropenia for patients with non-myeloid malignancies who are receiving treatment with myelosuppressive anti-cancer agents known to be associated with clinically significant neutropenia.

A biologics license application for pegfilgrastim-pbbk was accepted by the FDA for use in patients experiencing neutropenia while receiving chemotherapy.

OQ011, a topical ointment for hand-foot skin reaction-related pain, yielded positive safety and efficacy in part 1 of 2 phase 2 NOVA-II trial.

A label update for the CAR T-cell therapy product axicabtagene ciloleucel has been approved by the FDA to allow for use of prophylactic corticosteroid to manage cytokine release syndrome.

Fosnetupitant demonstrated non-inferiority and a favorable safety profile vs fosaprepitant for chemotherapy-induced nausea and vomiting.

Investigators reported that the development of cutaneous immune-related adverse effects has a strong association with response in survival among patients with cancer treated with immunotherapy.

A complete response letter has been issued to BeyondSpring Pharmaceuticals for plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

A phase 2 trial examining the use of small molecule immunomodulator EC-18 in patients with head and neck cancer experiencing chemoradiation-induced oral mucositis met its primary and secondary end points.

The FDA approved the first and only erythroid maturation agent for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.

The agency approved the first and only FDA-approved erythroid maturation agent to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.

A new study has revealed that the amount of iron in the blood affects the amount of the Scribble protein, which appears to control receptors that create new red blood cells.

Using a super computer, a team at Brown University has created a model of sickle cell anemia, devising a method that could help researchers assess and evaluate treatments to combat sickle cell disease.