“The European Commission approved bevacizumab (Avastin) in combination with erlotinib (Tarceva) as a frontline treatment for patients with unresectable advanced, metastatic, or recurrent EGFR-mutant non–small cell lung cancer (NSCLC).
“The approval was based on findings from the phase II JO25567 study, which showed a 46% reduction in the risk of progression or death with the combination versus single-agent erlotinib. The median progression-free survival (PFS) with the addition of bevacizumab was 16 versus 9.7 months with erlotinib alone (HR, 0.54; 95% CI, 0.36-0.79; P = .0015).
“ ‘The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,’ Sandra Horning, MD, chief medical officer and Global Head of Product Development at Roche, the company developing the combination, said in a statement. ‘This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond 1 year, representing important progress for a group of patients who typically face a poor prognosis.’ ”
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“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved the use of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy for the neoadjuvant treatment (use before surgery) of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the EC based on pCR data.
“Every year in Europe nearly 100,000 people are diagnosed with HER2-positive breast cancer, an aggressive type of the disease that is more likely to progress than HER2-negative cancer.1,2 Treating people with breast cancer early, before the cancer has spread, may improve the chance of preventing the disease from returning. Neoadjuvant treatment is given before surgery and is aimed at reducing tumour size so it is easier to surgically remove. pCR is achieved when there is no tumour tissue detectable at the time of surgery in the affected breast or in the affected breast and local lymph nodes. It is a common measure of neoadjuvant treatment effect in breast cancer and it can be assessed more quickly than traditional endpoints in eBC.
“ ‘Today’s approval is a significant milestone in the neoadjuvant treatment of HER2-positive early breast cancer, bringing Perjeta to patients years earlier than typical adjuvant treatment,’ said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. ‘We are committed to making the Perjeta regimen available to appropriate patients in the EU as early as possible.’ “
“The European Commission has approved the PD-1 inhibitor pembrolizumab (Keytruda) as a treatment for adult patients with unresectable or metastatic melanoma in the first-line and previously treated settings, based on data from 3 clinical trials that assessed the medication in more than 1500 patients.
“The European Commission decision follows a recommendation from Committee for Medicinal Products for Human Use, and allows for the medication to be marketed across 28 European Union member states. The medication is approved at a dose of 2 mg/kg every 3 weeks. In the 834-patient phase III KEYNOTE-006 study, pembrolizumab demonstrated an extension in overall survival (OS) and progression-free survival (PFS) compared with ipilimumab. Additionally, in the 540-patient phase II KEYNOTE-002 study, pembrolizumab improved PFS versus chemotherapy, with OS data pending maturity.
“ ‘Today’s European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world,’ Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, said in a statement. ‘We believe that the broad data set supporting this approval helps illustrate the significant potential of Keytruda to treat advanced melanoma, a devastating disease.’ “
“Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Commission has approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) after prior chemotherapy. This approval marks the first major treatment advance in SQ NSCLC in more than a decade in the European Union (EU). Nivolumab is also the first and only PD-1 immune checkpoint inhibitor to demonstrate overall survival (OS) in previously-treated metastatic SQ NSCLC. This approval allows for the marketing of nivolumab in all 28 Member States of the EU.
“ ‘With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care,’ said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. ‘Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal.’ “
The gist: Prostate cancer patients in the EU can now be treated with the drug enzalutamide (aka XTANDI). The European Commission approved the drug for adult men with metastatic castration-resistant prostate cancer (nCRPC) who have no symptoms or mild symptoms after failed treatment with androgen deprivation therapy, and who are not yet eligible for chemotherapy treatment. In a clinical trial with volunteer patients, enzalutamide gave men 17 extra months before chemotherapy was needed.
“Astellas Pharma Europe Ltd. today announced that the European Commission (EC) has granted a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI™).1 Enzalutamide is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.1
“ ‘Enzalutamide provides a viable treatment option for a broad population of men with mCRPC, regardless of age, or their readiness for chemotherapy, which provides a meaningful period of time during which men have their disease controlled without the need for chemotherapy’, said Professor Bertrand Tombal, MD, PhD, Chairman of the Division of Urology and Professor of Physiology, Université Catholique de Louvain (UCL) and European Principal Investigator for PREVAIL. ‘The decision from the European Commission to approve enzalutamide, an effective and well tolerated alternative to chemotherapy, is a very important milestone for men with prostate cancer that has advanced.’
“The Marketing Authorisation approval is based on results from the pivotal phase III PREVAIL study which demonstrate that enzalutamide improves outcomes for men with advanced prostate cancer who have not received chemotherapy.2″
The gist: Lung cancer patients in the EU will now be able to take the drug Vargatef (aka nintedanib) in combination with the chemotherapy drug docetaxel. The treatment has been approved by the European Commission for adults with locally advanced, metastatic, or locally recurrent non-small cell lung cancer (NSCLC).
“The European Commission granted marketing authorisation for Vargatef (nintedanib) in combination with docetaxal for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) after first-line chemotherapy.
“Prof Klaus Dugi, Boehringer’s chief medical officer, said: ‘The approval of Vargatef expands our oncology portfolio, following last year’s approval of Giotrif (afatinib) for another specific type of lung cancer.’
“The launch of Giotrif/Gilotrif in 2013 as a treatment lung cancer patients who express epidermal growth factor receptor (EGFR) marked Boehringer’s entry onto the oncology market.
“The addition of Vargatef widens the potential patient base for the German company, allowing Boehringer to make sizeable inroads into lung cancer.”
Editor’s note: When a newly developed drug for a rare (“orphan”) disease seems particularly promising for patients, the European Commission may choose to grant it “orphan drug designation.”The designation removes certain barriers that might otherwise keep a drug company from being able to successfully develop and profit from the drug in Europe. A new drug called IPH4102 has just received an orphan drug designation for the treatment of cutaneous T-cell lymphoma (CTCL).
“Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH), the innate immunity company developing first-in-class drug candidates for cancer and inflammatory diseases, today announced that the European Commission has granted orphan drug designation to IPH4102 for the treatment of cutaneous T-cell lymphoma (CTCL).
“CTCL is a group of rare cutaneous lymphomas of T lymphocytes with poor prognosis and few therapeutic options at advanced stages. IPH4102 is a first-in-class cytotoxic anti-KIR3DL2 antibody, aiming at destroying CTCL cancer cells.
Hervé Brailly, Chief Executive Officer and co-founder of Innate Pharma, said: ‘This decision by the European Commission validates the IPH4102 approach in a disease with significant medical need and supports our strategy for a rapid clinical development’.
“Phase I trial with IPH4102 is expected to begin in 2015.”
Editor’s note: A new treatment for chronic lymphocytic leukemia (CLL) has been approved in Europe, meaning that oncologists in Europe can now start prescribing it to their patients. The treatment is specifically meant for people with CLL who have not yet been treated but who have other conditions that make them unable to use standard full-dose fludarabine-based treatment. The new treatment combines a drug called Gazyvaro with the chemotherapy drug chlorambucil. Gazyvaro is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer.
“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Outside of the EU and Switzerland, Gazyvaro is marketed as Gazyva.
“ ‘We are proud to make Gazyvaro available for CLL patients in Europe,’ said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. ‘Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions.’ ”
“The European approval was based on the outcomes of the CLL11 study which was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly reducing the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil (progression free survival; PFS). For patients in the Gazyvaro arm, median PFS was 26.7 months compared with 15.2 months for those in the MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.001).
“Additional Gazyvaro data from the CLL11 study showed higher complete response rates (21% compared with 7%) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity* (37.7% compared with 3.3%) compared to the MabThera/Rituxan arm of the study.”
“The European Commission has given marketing authorization for trametinib as monotherapy for unresectable or metastatic melanoma in adults with a BRAF V600 mutation, GlaxoSmithKline announced.
“Trametinib (Mekinist), a kinase inhibitor that targets MEK1/MEK2 activation and kinase activity, has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Before taking trametinib, patients must have confirmation of a BRAF V600 mutation using a validated test.”
Editor’s note: The European Commission (the executive body of the European Union) has approved the drug trametinib (brand name Mekinist) as a treatment for unresectable or metastatic melanoma in adults whose tumors have a mutation called V600 in the BRAF gene. The approval is based on promising results for the drug in a clinical trial.