US firms Gloucester Pharmaceuticals and Allos Therapeutics have received the backing from advisers to the country’s regulator for their respective lymphoma drugs.

First up, Gloucester says that announced today that the US Food and Drug Administration’s Oncologic Drug Advisory Committee voted ten in favour with one abstention to recommend approval of romidepsin to treat patients with cutaneous T-cell lymphoma, a type of non-Hodgkin's lymphoma which affects about 1,500 people each year in the USA. The panel reviewed Phase IIb data of the drug, a histone deacetylase) inhibitor, which showed that patients on romidepsin had an overall response rate of 34%, which easily exceeded the primary endpoint of the study (ie above 15%). The median duration of response was 14.9 months.

The recommendation wraps up a good week for Gloucester, which has just raised $29 million in a series D financing, led by new investor Novo A/S. Some of the cash will be used to advance a second pivotal trial of romidepsin in peripheral T-cell lymphoma (PTCL) and Gloucester noted that the drug is also being evaluated in “multiple additional indications, including multiple myeloma”.

As for Allos, the ODAC voted ten to four that the response rate and the duration of that response observed with Folotyn (pralatrexate) are “reasonably likely to predict clinical benefit” in patients with relapsed or refractory PTCL. If approved, Folotyn would be the first drug approved by the FDA for the treatment of the disease, which accounts for 10%-15% of the 66,000 newly-diagnosed cases of NHL in the USA.

The recommendation is based on results from a Phase II trial conducted under an FDA’s special protocol assessment process. The data showed that 27% of patients with PTCL responded to treatment, a figure which the four panellists who voted against believe is on the low side.

The FDA is expected to make a final decision on Folotyn by September 24.