An extra cancer indication for Bayer’s Nexavar was among the latest set of drug recommendations from the European Medicines Agency (EMA).
Although the Agency’s Committee for Medicinal Products for Human Use (CHMP) this month backed just one new drug in the form of GlaxoSmithKline’s skin cancer drug Mekinist (trametinib), it recommended seven licence extensions for already-approved drugs, including the use of Nexavar (sorafenib) in people with advanced thyroid cancer.
If sanctioned by the European Commission the indication would add to Nexavar’s existing recommendations in the liver and kidney cancer.
The latest indication specifically covers the use of Nexavar to treat advanced forms of differentiated thyroid cancer, the third most common type of thyroid cancer. Around 37,000 new cases of thyroid cancer were reported in 2012 and over 3,600 people died from the disease.
There are few current treatment options for the cancer, which is generally treated with radioactive iodine, surgery and therapy to suppress thyroid-stimulating hormone.
As such, Nexavar’s recommendation could be an important step in the field, and covers its use in patients who no longer respond to treatment with radioactive iodine.
Pradaxa in DVT and PE
Meanwhile, competition among the new generation of anticoagulants continued to heat up as Boehringer Ingelheim received a new recommendation for the use of Pradaxa (dabigatran etexilate) in the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
This adds to its existing indications in the prevention of stroke in patients with non-valvular atrial fibrillation and in the prevention of blood clots in adults who have an operation to replace a hip or knee.
Assuming the CHMP recommendation translates into full approval for the PE and DVT indication it would put Pradaxa in line with rival Xarelto from Bayer and a step ahead of Eliquis from Pfizer/Bristol-Myers Squibb, each of which is also looking to establish itself as a safer, more convenient alternative to warfarin.
HPV vaccines
The remaining CHMP opinions this month included updated indications for two vaccines for human papillomavirus vaccine – a cause of cervical cancer.
Both Sanofi’s Gardasil and Merck & Co’s Silgard are recommended to have their indication revised to prevent the following in children as young as nine: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic HPV types. They both also have a genital warts indication.
Other new indications
Elsewhere, Janssen’s antipsychotic Invega (paliperidone) was backed to expand its use to include schizophrenia patients as young as 15 and the CHMP recommended revised indications for Novartis’ Gilenya (fingolimod) and Amgen’s Prolia (denosumab).