Pre-exposure prevention of COVID-19 approved

The TGA has granted provisional approval for the combination of tixagevimab and cilgavimab (Evusheld, AstraZeneca) for the prevention of COVID-19 in immunocompromised people.

Pre-exposure prophylaxis of COVID-19 is available for people aged 12 years and older weighing at least 40 kg:

• who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination; or
• for whom vaccination is not recommended due to a history of severe adverse reaction to a COVID‐19 vaccine or COVID‐19 vaccine component.

The provisional approval is based on evidence from the PROVENT Phase III pre-exposure prevention trial which found Evusheld significantly reduced the risk of developing symptomatic COVID-19 for at least six months.

Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

Gemtuzumab on the PBS for AML

Gemtuzumab (Mylotarg, Pfizer) has been PBS listed for patients 15 years and over with previously untreated, de novo, CD33-positive acute myeloid leukaemia in combination with intensive chemotherapy

The first-in-class treatment is not available for patients with acute promyelocytic leukaemia or those who have a known unfavourable cytogenetic profile.

The decision is underpinned by evidence of superior efficacy over standard of care in terms of event-free survival but remaining uncertainty regarding overall survival.

“The PBAC acknowledged the clinical input received from the Haematology Society ofAustralia and New Zealand and the   Australasian Leukaemia and Lymphoma Group (ALLG), as well as the advice from the ESC and other consumers, which confirmed that gemtuzumab ozogamicin would most likely be used for treatment in patients with favourable/intermediate cytogenetic risk, who are not FLT3-mutation positive and who are not being considered for HSCT,” the November 2021 PBAC meeting summary said.

Sexism at Melbourne University leads to loss of biomedical research grants

Philanthropic donor the Snow Medical Research Foundation has suspended the University of Melbourne from its biomedical fellowship program in protest at the university’s gender bias.

The foundation, which has donated over $90 million to medical research in the last two years, said Melbourne University’s recent awarding of honorary doctorates to six white men was the last straw. It noted that in the last three years, not a single honorary doctorate has been awarded to women or someone of non-white descent.

The foundation said the university’s policies on gender equality and diversity were not matched by its actions.

“This is unacceptable. We would have preferred not to have taken this step, but now is the time for action – not just talk,” it said.

In 2021 the Snow Foundation funded fellowships worth $8 million each to cancer researchers at the Peter MacCallum Cancer Centre, Melbourne, the Garvan institute of Medical Research, Sydney and the University of Melbourne.