BMS’s Opdivo is on track to add resected high-risk advanced melanoma to its current list of indications, after receiving a priority review from the US FDA. The regulatory agency has already granted Opdivo breakthrough therapy designation for this setting, marking its seventh such designation. Murdo Gordon, Chief Commercial Officer at BMS, said: “Priority review of
Thyroid cancer patients in the UK could potentially lose access to Ipsen’s Cometriq and Sanofi Genzyme’s Caprelsa via the Cancer Drugs Fund due to NICE rejecting funding for their use. The cost regulators have published draft guidelines rejecting their routine commissioning on the NHS in England and Wales to treat unremovable, locally advanced or metastatic
Novartis’ Afinitor and Pfizer’s Sutent have gained backing from NICE as cost-effective treatment options for certain neuroendocrine tumours (NETs). The public body has published final guidelines recommending both drugs for ‘routine’ NHS commissioning when NETs of the pancreas cannot be operated on and have progressed.
Patients with soft tissue sarcoma in England and Wales look set to gain routine NHS access to Eli Lilly’s Lartruvo after NICE backed funding for the drug in draft guidelines. Lartruvo in combination with doxorubicin has been recommended by the cost regulators as an option for advanced soft tissue sarcoma in adults who have not
Bayer announces that its investigational blood cancer treatment, copanlisib, has been awarded priority review designation from the FDA, thereby meaning the regulator pledges to review the product within a six-month timeframe. The blood cancer drug is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. It is indicated
EU regulators have issued approval for the first immunotherapy for high-risk neuroblastoma, which will offer a new treatment option to thousands of children affected by the rare and devastating form of cancer. EUSA Pharma’s dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen (GD2) on neuroblastoma cells, now indicated to treat
For the first time in the EU, patients with a form of lung cancer will be able to get treatment with Merck & Co’s immunotherapy Keytruda as a first-line of attack instead of chemotherapy, following a green light from European regulators in this setting. The European Commission has approved Keytruda for the first-line treatment of
Various UK biotechs have stated the current system in England for assessing treatments for extremely rare diseases is “not fit for purpose” and needs to change. The BioIndustry Association made the statement in a response to proposals to change the way highly specialised drugs and health technologies are evaluated for NHS use.
NICE has backed Celgene’s multiple myeloma pill Imnovid in combination with dexamethasone for use on the NHS in new draft guidance. Imnovid has been given approval for the treatment of people with relapsed or refractory multiple myeloma that have already undergone three previous treatments, including Celgene’s Revlimid and Takeda’s Velcade. The U-turn by the UK
Roche Group announced today that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of