Regulation & Policy

MorphoSys AG has secured regulatory approval from the US Food and Drug Administration for its first proprietary antibody therapeutic, Monjuvi (tafasitamab), to treat adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). The approval was based on data from the Phase 2 L-MIND study, a multicentre, single arm trial of Monjuvi in combination with lenalidomide, a drug for multiple myeloma. DLBCL is the most common type of non-Hodgkin lymphoma that can develop in the lymph nodes or any organ of the body.

A new chimeric antigen receptor (CAR) T cell therapy has been approved for cancer – only the third such therapy to be authorised by the US Food and Drug Administration. The drug is Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for the treatment of mantle cell lymphoma, a rare form of B cell non-Hodgkin’s lymphoma which usually occurs in middle-aged or older adults.

AstraZeneca Plc has announced the US approval of its triple-combination therapy, Breztri Aerosphere, for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The drug combines budesonide, an inhaled corticosteroid, with glycopyrrolate, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting beta2 agonist.

The checkpoint antibody Keytruda has been approved as a first-line treatment for a certain type of metastatic colorectal cancer, bringing the number of US cancer indications for the drug up to 28. The approval was based on the results of a Phase 3 trial in which Keytruda was shown to reduce the risk of disease progression or death by 40% compared with chemotherapy, the current standard of care. Patients in the trial had metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

The US Food and Drug Administration has approved a new treatment for seizures associated with Dravet syndrome, but with a warning that the drug is associated with valvular heart disease and pulmonary arterial hypertension. The drug, Fintepla (fenfluramine), is an amphetamine derivative.

After reviewing data from a US trial of remdesivir, the European Medicines Agency is recommending that the anti-viral treatment be given a conditional marketing authorisation to treat patients in the EU with COVID-19-associated pneumonia who require supplemental oxygen. The recommendation now goes to the European Commission for approval.

Emer Cooke, currently a director at the World Health Organization, has been nominated to become the new executive director of the European Medicines Agency, succeeding Guido Rasi whose term ends on 15 November. Ms Cooke is scheduled to address a committee of the European Parliament on 13 July, after which the appointment will be finalised.

The US Food and Drug Administration is to set up a trial website to provide retrospective data on how patients responded to oncology treatments during a clinical trial leading up to the approval of a new drug. The data is already used by the agency in the drug review process but to date, has not been made publically available.

Regulatory authorities in the US and EU have taken further steps to align their practices in light of the coronavirus pandemic. Officials from the two regions already hold regular conversations about issues relating to the authorisation of new medicines. Now they are broadening their discussions to consult on pandemic issues such as the use of real world evidence to better understand the epidemiology of COVID-19.

The UK government has approved the use of a generic corticosteroid, dexamethasone, for the treatment of patients in hospital with COVID-19 that require oxygen, including those on ventilators. This follows the results of a clinical trial conducted by the University of Oxford which showed that the drug can reduce the risk of death of patients on ventilation by as much as 35% and those on oxygen by 20%.