Jan 18 · Novartis has announced withdrawal of ofatumumab for CLL from markets outside the US due to low numbers of patients using the treatment. The company will set up compassionate use programmes so that current patients can continue treatment. Development will continue for refractory NHL and multiple sclerosis .
Dec 16 · Licence change approved in EU .
Nov 16 · EU positive opinion for a change to the licence to include use in combination with fludarabine and cyclophosphamide for treatment of adults with relapsed CLL .
Aug 16 · FDA approves licence extension of ofatumumab to include use with fludarabine and cyclophosphamide for treatment of relapsed chronic lymphocytic leukaemia .
Jun 16 · Filed in EU .
Mar 16 · Filed in the US .
Oct 15 · Filings are now expected to take place in 2016 .
Jul 15 · Filings planned for 2015 .
Jun 15 · Novartis took over development of GSK oncology products in H1 2015 .
Apr 15 · Novartis plans to share COMPLEMENT 2 data with regulatory agencies to assess the potential for future filings .
Jun 14 · In view of negative PIII results, GSK & Genmab do not anticipate applying for a licence extension in this specific population .
Apr 14 · Ofatumumab has been awarded orphan drug status in the US when used as second-line therapy or greater for CLL .
Apr 14 · EU filing will be via the centralised procedure .
Nov 08 · Granted orphan designation (EU/3/08/581) by the European Commission for treatment of CLL .