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NICE recommends Celgene's REVLIMID for multiple myeloma

NICE has issued a Final Appraisal Document (FAD) recommending Celgene’s REVLIMID (lenalidomide) as maintenance treatment after an autologous stem cell transplantation (ASCT) for newly diagnosed multiple myeloma in adults.

From today, approximately 1150 eligible patients in England will have immediate access to lenalidomide as a treatment option, with interim funding provided via the Cancer Drugs Fund before transferring to baseline commissioning.

NICE opts to reject Celgene's Revlimid for newly diagnosed multiple myeloma after an autologous stem cell transplant

It has emerged that NICE has opted to reject Celgene’s Revlimid (lenalidomide) for the maintenance of newly diagnosed multiple myeloma in adult patients who have received an autologous stem cell transplant on the NHS in England and Wales.

While clinical data indicated that Revlimid successfully extended progression-free survival and overall survival, NICE pointed out that treatments that patients were given after initially receiving Celgene’s therapy did not match up to standard NHS England practice, complicating any estimates over the benefit it could provide patients.

NICE recommends Celgene's Revlimid combo for follicular lymphoma

NICE has chosen to recommend Celgene’s Revlimid (lenalidomide) for use on the NHS, it has emerged, alongside Genentech’s Rituxan (rituximab), as an intervention for previously treated follicular lymphoma (FL) of grade 1 to 3A.

According to Celgene, this now means that 600 patients in England who were “previously limited to clinical trials or palliative care” will now be able to access the drug immediately “with interim funding provided via the Cancer Drugs Fund”.

Celgene and Acceleron's Reblozyl secures FDA approval for anaemia in beta thalassaemia

The FDA has moved to authorise Celgene and Acceleron Pharma’s Reblozyl (luspatercept-aamt) in the treatment of anaemia associated with the rare hereditary blood disorder beta thalassaemia, it has emerged.

The decision relates specifically to adult patients who require regular red blood cell (RBC) transfusions and makes Reblozyl the first and only erythroid maturation agent approved by the US regulator to treat the condition. However, the authorisation does not cover the therapy’s use as a substitute for RBC transfusions in patients who require immediate correction of anaemia.

Celgene signs $1.5bn partnership with Immatics to fight cancer with engineered T-cell therapies

Celgene and biopharma firm Immatics Biotechnologies have announced that they have entered a partnership valued at a potential $1.5 billion to pursue the development of T-cell receptor-engineered T-cell therapies (TCR-T) for a range of cancer types.

The pair will leverage Immatics’ XPRESIDENT technology and XCEPTOR TCR discovery and engineering platform to develop immunotherapies based on the method of engineering T-cells of patients to express a specific receptor.

Celgene's Otezla becomes first and only FDA-approved therapy for oral ulcers in Behçet’s Disease

Celgene has revealed the US approval of Otezla (apremilast), confirming that the FDA awarded marketing authorisation for the treatment of with oral ulcers in adult patients with the rare and chronic inflammatory condition Behçet’s Disease, making it the first and only therapy approved in this indication by the US regulator.

Just around five in 100,000 people are affected by the condition, with painful oral ulcers occurring in 98% of these cases.

Bristol-Myers Squibb to sell off Celgene's Otezla ahead of $74 billion merger

Bristol-Myers Squibb has agreed to sell off Celgene’s psoriasis treatment Otezla, to appease antitrust regulators.

BMS will divest one of Celgene’s most lucrative drugs as the two companies prepare for their $74 billion merger. Otezla generated $1.86 billion in sales last year and was previously seen as an important driver of future growth.

However, in light of discussions with the US Federal Trade Commission (FTC), BMS will sell off the psoriasis drug as quickly as possible. BMS expects this date to be in late 2019 or early 2020.

FDA first as agency expands label on Celgene's Revlimid in previously treated follicular or marginal zone lymphoma

Celgene has revealed that the FDA has expanded its authorised indications of Revlimid (lenalidomide) to include combination with a rituximab product (R²) as a therapy for previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL), marking the first approval for the US regulator in these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy.

Phase 3 data submitted in support of the application showed that the combo therapy demonstrated a “statistically significant” improvement in median progression-free survival (PFS) compared to rituxima

NICE recommends Celgene's Revlimid in treatment-naive multiple myeloma

Celgene’s Revlimid (lenalidomide) has been recommended by NICE for use on the NHS in England and Wales in combination with dexamethasone in the treatment of previously untreated multiple myeloma, the company has announced. The expanded indication relates specifically to adult patients who are not eligible for stem cell transplant and only where thalidomide cannot be tolerated or is contraindicted.

Sorrento Therapeutics seek $1 billion from billionaire biotech investor Patrick Soon-Shiong

Image Credit: NHS Confederation

Sorrento Therapeutics is seeking $1 billion in damages from billionaire biotech investor Patrick Soon-Shiong, owner of US newspaper the LA Times.  

The legal action comes after Sorrento accused Soon-Shiong of “catching and killing” a generic version of a cancer drug, which would have acted as competition to one owned by Celgene, a company in which he was the largest shareholder.

Sorrento claim Soon-Shiong acquired Cynviloq, a generic version of Celgene’s Abraxane, with the intention of stopping its progression to market.

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