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FDA clears Roche's breakthrough drug Gazyva

First drug approved in US under new scheme
Roche Basel Switzerland

Roche has the distinction of securing the first approval for a drug with the Food and Drug Administration's (FDA) new 'breakthrough' designation, getting the nod for its chronic lymphocytic leukaemia (CLL) treatment Gazyva.

The US regulator cleared Gazyva (obinutuzumab; formerly GA101) for use alongside the chemotherapy chlorambucil as a first-line therapy for CLL patients on the back of clinical data showing the combination doubled progression-free survival (PFS) versus chlorambucil alone.

The FDA noted that breakthrough status is reserved for new drugs that "offer a substantial improvement over available therapies for patients with serious or life-threatening diseases". CLL is one of the most common forms of blood cancer and is thought to cause the deaths of nearly 5,000 people each year in the US.

The phase III CL11 study enrolled 356 participants and found that those on Gazyva plus chlorambucil had an average PFS of 23 months, compared to 11 months for chlorambucil, equivalent to an 86 per cent improvement.

Gazyva has been approved with a boxed warning regarding hepatitis B reactivation as well as progressive multifocal leukoencephalopathy (PML), a rare disorder affecting the brain. Both are risks known to be associated with other monoclonal antibodies that share its mechanism of action (anti-CD20), such as Roche's $7bn-a-year Rituxan (rituximab).

Gazyva is being positioned as a replacement for Rituxan, which starts to lose patent protection in Europe later this year and in the US in 2018, and the new antibody has already proved more effective than its predecessor in both CLL and non-Hodgkin's lymphoma (NHL) in head-to-head trials.

Just how much better Gazyva performed than Rituxan in CLL will be revealed when Roche presents the data at the American Society of Hematology (ASH) conference in December.

Roche said its Genentech unit will launch Gazyva within the next two weeks, and analysts have predicted that peak sales could be between $1.5bn and $2.5bn.

Roche pointed out in a news release that it has now had five new cancer medicines approved in three years, and the firm's chief medical officer - Hal Barron - said: "We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancer."

In addition to CLL and NHL, Roche is also investigating the potential of obinutuzumab in diffuse large beta cell lymphoma (DLBL).

Article by
Phil Taylor

4th November 2013

From: Sales

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