FDA has granted accelerated approval to Janssen’s erdafitinib, a treatment for adult patients with locally advanced or metastatic bladder cancer. Which enables the drug to be used to treat bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. The
Bayer’s Regorafenib has received a final approval from NICE for use by the NHS to treat advanced liver cancer. Regorafenib is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had Sorafenib, however they can only receive the treatment if they have Child–Pugh grade A liver impairment and an Eastern
Pfizer’s lorlatinib has been assigned a “Promising Innovative Medicine” award for the treatment of some patients with ALK-positive advanced non-small cell lung cancer. The drug is currently under review by the European Medicines Agency for patients with the condition who have previously been treated with a second generation ALK tyrosine kinase inhibitor. The PIM award
Experts state that it is looking highly unlikely that Janssen’s Zytiga plus androgen deprivation therapy (ADT) and prednisone/prednisolone will become routinely available on the NHS as a first-line treatment for patients with high-risk hormone-sensitive metastatic prostate cancer. NICE have published draft guidelines rejecting the therapy in this setting, after concluding that the company’s economic
FDA has started a six-month review of Roche’s Tecentriq, Avastin and chemotherapy in first-line non-small cell lung cancer, setting up a possible approval for the start of September this year. The triple therapy is an important tactic for Roche to catch up as it tries to build a market for new immuno-oncology drug Tecentriq and
US regulators will conduct a priority review of MSD’s Keytruda to treat patients with advanced cervical cancer. The company is seeking approval for the drug’s use in patients with cervical cancer who experience disease progression during or post chemotherapy. The FDA’s decision marks the first filing acceptance and priority review issued for an anti-PD-1 therapy
The US regulators have approved a label update to BMS’s Opdivo, waving through a new dosing option for the immunotherapy of every four weeks. The company says the approval will allow physicians to customise patient care with the option of using the new dose of 480mg every four weeks in addition to the previously available
EUSA Pharma has gained backing from NICE for its first-line treatment for advanced renal cell carcimona (RCC), Fotivda. The recommendation from the UK’s regulatory body was decided on the result of the phase III trial TiVO-1, which evaluated the efficacy and tolerability of Fotivda compared to Bayer’s Nexavar.
NICE has supported NHS use of Janssen’s Darzalex via the Cancer Drugs Fund (CDF) for some adults with previously treated multiple myeloma. Darzalex is a humanised monoclonal antibody that works by binding to a signalling molecule found on the surface of multiple myeloma cells called CD38, with the aim to trigger the patient’s own immune
NICE have recommended Roche’s Tecentriq for use within the Cancer Drugs Fund (CDF) to treat advanced urothelial cancer in specific circumstances. In final draft guidelines issued by the public body, Tecentriq is being backed for use in patients whose urothelial cancer has not yet been treated and who aren’t suitable for cisplatin-based chemotherapy. At first
