Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January. Among the applications for new medicines to be reviewed is GSK’s Blenrep® (belantamab mafodotin) for the treatment of patients with multiple myeloma that has returned or did not respond to treatment.
Meanwhile, AbbVie’s Elahere® (mirvetuximab soravtansine) has been accepted for review for the treatment for adult patients with a specific type of ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy. Elahere® received EU approval for this indication in November 2024.
Applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:
- AstraZeneca’s Imfinzi® (durvalumab) for muscle invasive bladder cancer. Imfinzi® is already also under review by the TGA for the treatment of patients with limited-stage small cell lung cancer;
- Takeda’s Adcetris® (brentuximab vedotin) for the treatment of adult patients with previously untreated Hodgkin Lymphoma, in combination with other anti-cancer drugs;
- Janssen’s Darzalex SC® (daratumumab) for the treatment of patients with newly-diagnosed multiple myeloma who are ineligible for a stem cell transplant, and high-risk smouldering multiple myeloma; and
- Janssen’s Tremfya® (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis who are eligible for systemic (whole-body) therapy or phototherapy (ultraviolet light therapy.