CHMP recommends cancer ‘smart bomb’
pharmafile | September 23, 2013 | News story | Research and Development, Sales and Marketing | CHMP, Cancer, EMA, Kadcyla, Roche
A so-called cancer ‘smart bomb’ has been given the green light by the Committee for Medicinal Products for Human Use (CHMP) at its latest meeting.
Roche’s Kadcyla (trastuzumab emtansine) is one of the most eye-catching drugs approved by the key advisory body this time round.
Janssen’s new diabetes treatment Invokana (canagliflozin), a potential $1 billion selling brand, has also been given the thumbs up, as has GlaxoSmithKline’s chronic obstructive pulmonary disease (COPD) treatment Relvar Ellipta (fluticasone furoate/vilanterol).
The CHMP’s nod represents the major stepping stone towards market authorisation, which is likely to be announced for most of these drugs by the European Commission before the end of 2013.
Kadcyla, which was approved in February in the US and has also just been approved in Japan, combines the manufacturer’s own Herceptin and ImmunoGen’s DM1 chemotherapy in one molecule and is the first antibody-drug conjugate (ADC) for treating HER2-positive metastatic breast cancer (mBC).
It has been approved by the CHMP for patients in this group who had previously received Herceptin (trastuzumab) and a taxane chemotherapy.
It could make more than $1.1 billion in peak annual sales, analysts say, with trials showing it significantly delayed disease progression in HER2-positive mBC and produced fewer side effects.
The Phase III EMILIA study showed Kadcyla reduced the risk of disease worsening or death compared to GlaxoSmithKline’s Tyverb (lapatinib) plus Roche’s Xeloda (capecitabine).
Other trials in breast cancer are planned or underway, along with another in HER2-positive gastric cancer.
Meanwhile Janssen’s Invokana (canagliflozin) received a positive CHMP opinion for marketing authorisation for the treatment of type 2 diabetes mellitus.
The drug is in the new class of diabetes treatments called selective sodium glucose co-transporter 2 (SGLT2) inhibitors, blocking the reabsorption of glucose by the kidney, thus increasing glucose excretion and lowering blood glucose levels.
Analysts predict Invokana’s peak sales could reach $1 billion, but competition from its class rival – Bristol-Myers Squibb/AstraZeneca’s Forxiga (dapagliflozin), which gained European approval last year – will be fierce.
GlaxoSmithKline’s Relvar Ellipta, developed with Theravance, for asthma and COPD has also met with the CHMP’s approval: known as Breo in the US, Relvar’s 100/25mcg dose is administered by a new dry powder inhaler called Ellipta.
It will compete with drugs such as Boehringer Ingelheim and Pfizer’s Spiriva but saw mixed results in late-stage trials, failing to prove itself superior to GSK’s own Seretide (Advair in the US) – the blockbuster it is designed to replace.
However, COPD – chronic bronchitis and emphysema – is projected to be the third leading cause of death worldwide by 2020 and treatments are sought after.
The CHMP has also approved another oncology treatment, Bayer’s Xofigo (radium-223) for the treatment of castration-resistant prostate cancer.
Its active ingredient mimics calcium and targets bone and is cytotoxic to cancer cells of bone metastases – the drug’s benefits are its ability to improve survival and to delay skeletal-related events such as pathological fractures and spinal cord compression.
Elsewhere the CHMP has recommended a trio of medicines designed to treat neurological disorders: the first of these is Otsuka Pharmaceutical Europe’s Abilify Maintena (aripiprazole) for the maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
The advantage of the brand is the reduction in stabilised patients experiencing relapse in long term use, with a monthly administration instead of having to take it once a day.
Aripiprazole is a psycholeptic antipsychotic which is already authorised for schizophrenia in oral and rapid intramuscular forms.
The fight against Alzheimer’s disease continues with Accord Healthcare’s Memantine Accord (memantine) for the treatment of this degenerative brain condition.
The CHMP suggests it should be used as 5 mg, 10 mg, 15 mg and 20 mg, film-coated tablets for patients with moderate to severe Alzheimer’s.
It is the generic version of Axura, which has been authorised in the EU since May 2002, and the CHMP said no bioequivalence study with Axura was required.
The final one of the three is Orion Corporation’s Levodopa Carbidopa Entacapone Sandoz, which was submitted as a so-called ‘informed consent’ application, for the treatment of adult patients with Parkinson’s disease.
It is a combination of an immediate precursor of dopamine, a Dopa Decarboxylase inhibitor (carbidopa) and a COMT (Catechol-O-methyltransferase) inhibitor (entacapone).
Adding carbidopa to levodopa increases its availability into the brain, offering the possibility of decreasing the levodopa dose by an average of 75%: using entacapone with the two enhances the way levodopa works in the brain, mitigating its side effects.
The CHMP also recommended that Gilead Sciences International’s anti-HIV drug Vitekta (elvitegravir) should be granted marketing authorisation to treat adults infected with HIV-1 but who do not have known mutations associated with resistance to elvitegravir.
The HIV-1 integrase strand transfer inhibitor prevents the integration of HIV-1 DNA into host genomic DNA, blocking the formation of the HIV-1 provirus and stopping the viral infection spreading.
In further decisions, Novo Nordisk’s NovoEight (turoctocog alfa) was recommended for the treatment of haemophilia A, with MedImmune’s vaccine Fluenz Tetra (influenza vaccine – live attenuated, nasal) given the nod for the prevention of flu in children and adolescents from 24 months to less than 18 years old.
Plethora Solutions’ Lidocaine/Prilocaine (lidocaine/prilocaine) has been recommended for the treatment of primary premature ejaculation in adult men.
The CHMP also recommended extensions to the existing indications for UCB Pharma’s Cimzia (certolizumab pegol), Biovitrum’s Kineret (anakinra), Novartis’ Votubia (everolimus) and Bristol-Myers Squibb’s Yervoy (ipilimumab)
Finally, the committee started separate re-examination procedures for dihydroergotoxine and for metoclopramide-containing medicines.
Adam Hill
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