Regulation & Policy

The US Food and Drug Administration has approved a new device for treating patients with chronic heart failure who are not suited for other interventions such as cardiac resynchronisation therapy. The device is indicated to improve a patient’s ability to perform a six-minute walk and improve his or her quality of life. These are patients who have a marked limitation of physical activity and who remain symptomatic despite receiving optimal medical therapy.

The European Commission is to allocate more than €2 billion for the final two years of an experimental programme intended to nurture entrepreneurs and start-up companies across Europe.

The checkpoint antibody Tecentriq (atezolizumab) received its fifth approval from the US Food and Drug Administration on 8 March – this time for triple-negative breast cancer. The approval is for the use of Tecentriq in combination with chemotherapy for patients with breast cancer whose tumours express the PD-L1 protein. Patients will be identified using a new FDA-approved assay.

The US Centers for Medicare and Medicaid Services (CMS) has proposed to reimburse cancer treatments with chimeric antigen receptor (CAR) T cell therapies under a policy called ‘Coverage with Evidence Development.” Currently there is no national Medicare policy for covering CAR T cell therapy so local Medicare contractors will have discretion over whether to pay for it. The proposed coverage would require Medicare to cover the therapy when it is offered in a CMS-approved registry or clinical study in which patients are monitored for at least two years after treatment.

Scott Gottlieb, commissioner of the US Food and Drug Administration, has resigned his position reportedly in order to spend more time with his family in Connecticut. The FDA job involved a weekly commute to Washington DC, a distance of about 277 miles.

Announced on 5 March, the resignation is expected to take effect in about a month. It was confirmed in a tweet by President Trump who praised Dr Gottlieb for his work leading the drug regulatory authority, a job that he has held since May 2017.

An approach to drug payments, where the price of a new medicine is linked to its effectiveness, may enable patients suffering from cancer to get new treatments faster, according to Cancer Research UK.

The European Medicines Agency (EMA) has been told it will have to continue servicing the lease covering its former London headquarters even as it completes plans for a move to Amsterdam. The move to Amsterdam follows the UK’s 2016 vote to leave the EU.

The UK High Court ruled on 20 February that the move “was not required as a matter of law.” Therefore the agency’s rental contract remains in force along with the landlord’s right to collect rent. The case was brought by the property company Canary Wharf Ltd.

The EMA is reportedly studying its options for an appeal.

The US Food and Drug Administration has given ‘fast track’ status to a prospective antibody treatment wholly-owned by Innate Pharma SA for the treatment of Sézary syndrome, an aggressive form of cutaneous T cell lymphoma.

A fast track designation enables the developers of promising drugs the opportunity for an expedited review. In this case the drug, IPH4102, produced favourable Phase 1 data in adult patients who had relapsed after receiving at least two prior therapies.

A wave of clinical trial applications for new cell and gene therapies has reached the US Food and Drug Administration triggering a review of clinical guidance documents for developers. In an announcement on 15 January, Scott Gottlieb, the FDA commissioner, said new guidances are being drafted for gene replacement therapies as well as for cell-based gene therapies such as the chimeric antigen receptor (CAR) T cell drugs.

The US Food and Drug Administration has approved a new indication for Lynparza (olaparib) for the maintenance treatment of adults with suspected germline BRCA-mutated advanced ovarian cancer.