TGA plans fast track approval for oncology biologics
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologics that could see them approved within six months.
The proposed ‘Priority Review’ pathway will offer a faster formal assessment pathway for new or new use biologicals for people with a life-threatening disease or seriously debilitating condition. Under the proposals released for consultation a biologic would have to fulfil an unmet clinical need or offer a clinically significant improvement over already approved therapeutic goods to be eligible for fast track review.
According to the TGA, the priority pathway will only be open to biologics that have substantial evidence demonstrating that it “provides a major therapeutic advantage in patient outcomes when compared to existing treatments as defined by a magnitude well beyond the minimum threshold of clinical significance.”
This will require endpoints that directly demonstrate clinical benefit such as overall survival and progression-free survival for oncology-based biologicals, the TGA says.
The TGA says the pathway will build on the lessons learned from existing fast track review pathways offered by regulatory bodies such as the European Medicines Agency (150 days) and the FDA (six months).
“This will allow consumers with life-threatening diseases or seriously debilitating conditions to access these treatments in less time if the assessment results in a decision by the TGA to include the biological in the Australian Register of Therapeutic Goods (ARTG),” it says.
Covid curbs pharma sponsorship of doctor meetings
Pharmaceutical industry spending on hospitality for doctors attending medical education events fell by 40% during the pandemic, according to new figures released by industry lobby group Medicines Australia.
In its transparency report for the period 1 November 2020 to 30 April 2021 the total expenditure reported by companies on hospitality was $364,332, down from $594,474.
There were 721 medical education events sponsored during the six month period at a total costs of $5.96 million covered by the report, compared to spending of $5.63 million on 804 events in the same period a year previously.
The total hours of education supported by industry sponsorship declined from 6253 hours to 4934 hours.
The number of healthcare professional attendances at industry sponsored events fell from 165,455 to 148,810.
The pandemic forced most medical meetings to be transformed into virtual meetings and a recent pharmaceutical industry survey showed that most companies expected a significant level of virtual engagement with healthcare professional to be maintained in future.
Genomic oncology program gets $185 million funding
Funded by a mix of government and industry sources the Precision Oncology Screening Platform Enabling Clinical Trials (PrOSPeCT) project aims to open up new genomic-based treatment paths for Australians with rare and difficult to treat cancers, its backers say.
According to researchers at the Garvan Institute, the public-private project will provide genomic screening through national adult and paediatric oncology networks, collect comprehensive clinical, pathologic, treatment and outcomes data on all patients, and function as a coordinating and enabling platform to increase collaboration between businesses that operate in the clinical trials and research ecosystem.
“Through PrOSPeCT, we will fast-track the development, manufacturing and use of precision, personalised cancer treatments, changing lives, creating jobs and building Australia’s sovereign capability in drug development,” said Professor David Thomas, head of Genomic Cancer Medicine at the Garvan Institute and CEO of the Australian Genomic Cancer Medicine Centre (Omico), the not-for-profit company leading the project.
The $62 million funding from the government is being supplemented with funding from partners including Roche Australia, Children’s Cancer Institute Australia (CCI) and The Minderoo Foundation.