Roche leukaemia drug granted speedy US review
pharmafile | July 3, 2013 | News story | Research and Development, Sales and Marketing | CLL, FDA, Roche, leukaemia, obinutuzumab
Roche’s investigational leukaemia drug could be available for US patients by the end of the year as the FDA looks to speed up its normal approval process.
The drug, obinutuzumab (GA101), has been granted a priority review by the US regulator for previously untreated chronic lymphocytic leukaemia (CLL).
The FDA confirmed the action date is 20 December 2013, and follows the drug’s ‘breakthrough therapy designation’ given by the regulator in May.
A priority review speeds up the usual assessment process and aims to have a decision on a medicine within six months, rather than the normal time of around one year.
Both this and the breakthrough status are reserved for medicines that treat serious and life-threatening diseases, meaning patients require them more quickly.
CLL is one of the most common forms of blood cancer, and in 2013 it is expected there will be nearly 5,000 deaths from CLL in the US.
Roche already has a drug on the market for the condition called Rituxan (known as MabThera in Europe), which in addition has licenses for non-Hodgkin’s lymphoma and autoimmune diseases. It brought in just under $7 billion for the firm last year, making it one of the world’s biggest selling drugs.
But in CCL Rituxan is only licenced for use with the chemotherapy medicines fludarabine and cyclophosphamide. If it gains approval, obinutuzumab will have a first-line setting, meaning it will be used earlier than Rituxan and should generate greater revenue.
Napp’s Levact (bendamustine) is also approved for the condition with a second-line licence for CLL, as well as non-Hodgkin’s lymphoma and multiple myeloma.
“We’re excited that the FDA has granted GA101 in CLL both breakthrough therapy designation and priority review,” said Hal Barron, chief medical officer at the Swiss firm.
“These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame.”
Roche has also sent marketing applications to other regulatory authorities, including the European Medicines Association in April. In Europe especially, Roche will look to ensure that its new drug will stop generic competition for Rituxan, which loses patent protection across the EU later this year.
The company said it was looking to further advance its haematology portfolio and highlighted a number of medicines in its pipeline, including two antibody-drug conjugates and in collaboration with AbbVie, a small molecule BCL-2 inhibitor.
Just yesterday the firm also announced the $220 million purchase of CMI, who specialise in creating haematology blood testing systems.
This rounds off a good week for Roche which was also granted a priority review for Perjeta for use before surgery in aggressive breast cancer. This too is a next-generation drug, and is looking to replace the firm’s ageing breast cancer treatment Herceptin.
Ben Adams
Related Content
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
