Roche's Perjeta Regimen Approved in Europe for Use Before Surgery in Early Stage Aggressive Breast Cancer

“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.’ “


European Commission Approves Pembrolizumab for Advanced Melanoma

“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.’ “


European Commission Approves Nivolumab BMS, the First PD-1 Immune Checkpoint Inhibitor in Europe Proven to Extend Survival for Patients with Previously-Treated Advanced Squamous Non-Small Cell Lung Cancer

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.’ “


ABRAXANE® Approved by European Commission for First-Line Treatment of Patients with Non-Small Cell Lung Cancer

“Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation CELG, -0.88% today announced that the European Commission (EC) has approved ABRAXANE® (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

“The ABRAXANE Marketing Authorisation has been updated across 28 member states in the European Union to include this new indication in non-small cell lung cancer (NSCLC), adding to the existing indications for the treatment of metastatic pancreatic and breast cancers.

“Lung cancer is the fourth most commonly diagnosed cancer in both men and women, however it is the leading cause of cancer-related mortality in Europe. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 to 90% of all cases. The predominant cause of lung cancer is cigarette smoking, although environmental and occupational factors also can cause the cancer.

“The EC decision follows the positive CHMP opinion received on 23 January and is based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. The study compared ABRAXANE in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. The primary efficacy endpoint, overall response rate, was significantly higher for patients in the ABRAXANE/carboplatin arm at 33%, compared with patients in the control arm, at 25%. The most common adverse reactions (greater-than or equal to 20%) of ABRAXANE in combination with carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.”


Early Access Program to Make ThermoDox Available in Europe for Patients with Recurrent Chest Wall Breast Cancer

The gist: Patients with recurrent chest wall (RCW) breast cancer in the European Union and Switzerland will now have access to a new treatment called ThermoDox. ThermoDox is a new way of delivering the chemotherapy drug doxorubicin. ThermoDox is spread throughout the body by the bloodstream, but it is not activated unless a doctor heats a body part to 39.5 – 42 degrees Celsius. That way, the patient can have the drug activated only to the part of the body where it is needed. Based on promising results in patients in clinical trials, ThermoDox will now be available in Europe in an Early Access Program.

“Celsion Corporation (NASDAQ:CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments,  today announced that it has signed a license and distribution agreement with myTomorrows to implement an Early Access Program for ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin, in all countries of the European Union (EU) territory plus Switzerland for the treatment of patients with recurrent chest wall (RCW) breast cancer.

“RCW breast cancer is difficult to treat and has a poor prognosis with a significant impact on a patient’s quality of life.  Patients with highly resistant tumors found on the chest wall often see their cancer progress despite previous treatment attempts including chemotherapy, radiation therapy and hormone therapy.  There are approximately 25,000 to 35,000 incidence of RCW breast cancer in the EU alone and thermal therapy is a well-accepted strategy for treating patients.  Recent findings from two Phase I studies and an ongoing open label Phase II study indicate that when combined with thermal therapy, ThermoDox can demonstrate significant overall response rates and tumor control in post mastectomy, refractory patients.”


Men Treated with Enzalutamide Experienced a 17-Month Delay in the Time to Initiation of Chemotherapy Compared to Placebo

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″


Boehringer's Vargatef Approved in the EU for Lung Cancer

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.”


Amgen Submits Marketing Authorization Application for Oncolytic Immunotherapy in EU

Editor’s note: Before a drug can be made widely available to patients in the European Union, it must first be approved by the European Medicines Agency. The drug company Amgen recently submitted a proposal for approval of its melanoma treatment talimogene laherparepvec (T-VEC). T-VEC is a modified virus that is injected directly into tumors, where it destroys tumor cells. It has shown some promising results in clinical trials—research studies in volunteer patients.

“Amgen announced the submission of a marketing authorization application to the European Medicines Agency for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma in adults.

“If the application is approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies, according to a company press release.

“The marketing authorization application contains data from more than 400 patients and is based on a global, randomized, open-label, phase 3 trial evaluating its efficacy and safety in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended.”


European Commission Approves Mekinist for Metastatic Melanoma

“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.