Roche’s Atezolizumab has won US clearance for use in combination with carboplatin and etoposide (chemotherapy) as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in the US, offering patients the first new treatment in more than 20 years. The approval follows data from the Phase III IMpower133 study, which showed that Atezolizumab in combination
The FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted in support of Esketamine nasal spray CIII for adults living with treatment-resistant depression. The decision came as a result of 14 yes votes, two no votes and one abstain, basing their support on the safety and efficacy data from
EMA’s CHMP committee has recommended Shire’s Lanadelumab, a new rare disease treatment which has blockbuster potential. Lanadelumab has been endorsed for prevention of recurrent attacks of hereditary angioedema (HAE) a rare, genetic disorder that results in recurring attacks of oedema in parts of the body, including the abdomen, face, feet, genitals, hands and throat. Laryngeal
NHS has three months to ensure that Novartis’ combination therapy dabrafenib/trametinib is routinely available to eligible skin cancer patients, after cost regulators published guidance backing funds for the treatment. NICE recommended the combination for use in patients with stage III BRAF V600 mutation-positive melanoma that has spread to lymph vessels, or lymph glands close to
Clovis Oncology’s Rucaparib has been designated as a Breakthrough Therapy by the FDA in prostate cancer, paving the way for a faster review if clinical trials achieves favourable results. The FDA has said that phase 2 data suggest the drug could represent a new therapy option for men whose cancer has progressed despite chemotherapy, and
AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The
Mepsevii has been approved for use in Europe to treat the ultra-rare disease mucopolysaccharidosis type VII (MPS VII), offering patients an approved treatment for the very first time. MPS VII, also known as Sly Syndrome, is a genetic metabolic lysosomal storage disorder, caused by the deficiency of beta-glucuronidase, an enzyme required for the breakdown of
NICE has recommend that three separate treatments for thyroid cancer should be made available for use on the NHS: Ipsen’s Cometriq, Bayer’s Nexavar, and Eisai’s Lenvima. The former two were previously only available via the Cancer Drugs Fund (CDF), and Eisai’s finally gains approval after delays of over two years. Eisai’s tyrosine kinase inhibitor was
GSK’s biologic Nucala is the first therapy specifically approved in the US to treat a rare disease called eosinophilic granulomatosis with polyangiitis (EPGA). EGPA is an autoimmune disease that causes vasculitis, which is an inflammation in the wall of blood vessels of the body. The disease is characterised by asthma, high levels of eosinophils, and
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
