Pharma Oncology | Top News – Spring 2016

GSK Returns to War against Cancer


April 3, 2016

It looked like the UK pharmaceuticals group GlaxoSmithKline (GSK) was declaring surrender in the war on cancer when the company agreed to sell its oncology drugs for $16 billion to Novartis in 2014. However, after two years, GSK returns to this war on cancer again.


FDA Grants Breakthrough Therapy Designation to Merck for KEYTRUDA® (pembrolizumab) in Classical Hodgkin Lymphoma (cHL)

merckApril 18, 2016

Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA® (pembrolizumab). This is the company’s anti-PD-1 therapy which is used for the treatment of patients with refractory or relapsed classical Hodgkin lymphoma (cHL). This is the fourth Breakthrough Therapy Designation granted for KEYTRUDA.


Study Reveals that Opdivo from Bristol-Myers extends survival in head and neck cancer


Apr 19, 2016

According to data from a late-stage study, the cancer immunotherapy drug of Bristol-Myers Squibb, Opdivo, assisted advanced head and neck cancer patients with a dismal prognosis live longer than other standard treatments.


AbbVie and argenx sign $685M deal for preclinical immuno-oncology


April 21, 2016

AbbVie, a global biopharmaceutical company, and argenx, a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for treating severe autoimmune diseases and cancer will work together to develop and commercialize ARGX-115. This is argenx’ preclinical-stage human antibody program that targets the novel immuno-oncology protein called GARP, which is believed to contribute to immuno-suppressive effects of T-cells.


AbbVie Agrees to Buy Stemcentrx


April 28, 2016

Pharmaceutical company AbbVie Inc. has agreed to acquire Stemcentrx Inc., a cancer-drug developer, for $5.8 billion. This is part of AbbVie’s continuing aggressive push for building an oncology business.


European Medicines Agency Issues Positive Opinion for the Use of IMBRUVICA® for Chronic Lymphocytic Leukaemia Patients


Apr 29, 2016

AbbVie, a global biopharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in favor of the use of IMBRUVICA® (ibrutinib) for treating adult patients with chronic lymphocytic leukemia (CLL). This follows the approval of U.S. Food and Drug Administration (FDA) IMBRUVICA for the first-line treatment of patients with CLL on March 4, 2016. This would be the fifth treatment indication for IMBRUVICA in the EU to date if approved by the European Commission (EC).


CHMP Recommends EU Approval for Roche’s Avastin in Combination with Tarceva for Treating Advanced Lung Cancer


29 April, 2016

Roche has announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for treating adult patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. The most common type of lung cancer is NSCLC, which is the major cause of cancer-related death in Europe and across the world. Nearly 10-15 percent of Europeans with NSCLC have tumors with EGFR-activating mutations, which represents an estimated 33,000 cases in Europe per year, or 90 every day.

Roche’s Gazyvaro is recommended by CHMP for EU approval for treating follicular lymphoma


April 29, 2016

Roche has announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro® (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance for the treatment of people with follicular lymphoma. Approximately 19,000 people in Europe are diagnosed with follicular lymphoma each year, which is the most common type of indolent (slow-growing) non-Hodgkin lymphoma. This sort of lymphoma is considered incurable, and the situation of most people deteriorate rapidly.

Bristol-Myers Squibb and AbbVie Announce the Approval of Empliciti™ (elotuzumab)by European Commission for the Treatment of Multiple Myeloma


May 11, 2016

Bristol-Myers Squibb Company and AbbVie has announced that the European Commission has approved Empliciti™ (elotuzumab) for treating multiple myeloma as combination therapy with dexamethasone and Revlimid® (lenalidomide) in patients who have received at least one prior therapy. Now, Empliciti is the first and only immunostimulatory antibody approved for multiple myeloma in the European Union (EU).

European Commission Approves the Immuno-Oncology Combination, Opdivo® (nivolumab) + Yervoy® (ipilimumab) Regimen of Bristol-Myers Squibb, for Treatment of Advanced Melanoma


May 11, 2016

Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved Opdivo in combination with Yervoy for treating advanced (unresectable or metastatic) melanoma in adults. This combination represents the first and only approved combination of two Immuno-Oncology agents in the European Union (EU). Due to this approval, it has become legitimate to market Opdivo + Yervoy Regimen in all 28 Member States of the EU.

Novartis Separates its Pharmaceuticals Division into two business units: Novartis Pharmaceuticals and Novartis Oncology


May 17, 2016

Novartis has announced that it has created two business units reporting to the CEO: Novartis Oncology and Novartis Pharmaceuticals. The Innovative Medicines Division at Novartis will be formed by these business units. The Executive Committee of Novartis (ECN) will be effective from July 1, 2016, and the leader of each business will join this committee. Bruno Strigini will become CEO of Novartis Oncology and Paul Hudson will be appointed as CEO of Novartis Pharmaceuticals. Both will report directly to CEO of Novartis, Joseph Jimenez. In the meantime, David Epstein, currently Division Head and CEO, Novartis Pharmaceuticals, has decided to leave Novartis.


New Data on Opdivo (nivolumab) from Bristol-Myers Squibb Indicate Benefit in Heavily Pre-Treated Classical Hodgkin Lymphoma Patients


June 10, 2016

Bristol-Myers Squibb Company has announced results from CheckMate -205, a multi-cohort, single-arm, non-comparative, Phase 2 registrational trial evaluating Opdivo (nivolumab) in classical Hodgkin lymphoma (cHL) patients. The results included patients who had relapsed or progressed after post-transplantation brentuximab vedotin and autologous hematopoietic stem cell transplantation (auto-HSCT). The primary endpoint of objective response rate (ORR) per an independent radiologic review committee (IRRC) was 66.3% (95% CI: 54.8-76.4). Median time to response was 2.1 months, and estimated median duration of remission was 7.8 months (95% CI: 6.6-NE). In an exploratory analysis, it was observed that over two-thirds (72.1%) of patients who did not respond to most recent prior brentuximab vedotin treatment did respond to Opdivo.

BLINCYTO® (Blinatumomab) Improved Overall Survival in Patients with B-Cell Precursor Acute Lymphoblastic Leukemia


June 10, 2016

Amgen has announced new data from an interim analysis of the Phase 3 TOWER study, in which BLINCYTO® (blinatumomab) confirmed nearly two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER study estimated the effectiveness of BLINCYTO versus SOC chemotherapy in adult patients with Philadelphiachromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Results from the analysis showed that median OS was 7.7 months (95 percent CI: 5.6, 9.6) for BLINCYTO compared to 4 months (95 percent CI: 2.9, 5.3) for SOC (stratified log-rank test p=.012; hazard ratio=0.71).

New Results from Pivotal Phase 3 Studies Show that Kyprolis® (Carfilzomib) Allows Patients with Relapsed Multiple Myeloma to Live Longer


June 10, 2016

Amgen has announced results from a post-hoc analysis of the pivotal Phase 3 ASPIRE study which emphasized the advantages of continued treatment with Kyprolis® (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) in patients with relapsed multiple myeloma. Furthermore, separate sub-analyses of the Phase 3 ENDEAVOR study confirmed depth and efficacy of response benefits of Kyprolis plus dexamethasone (Kd). These results were presented at the 21st Congress of the European Hematology Association (EHA).

Pharma Oncology | Top News – Spring 2016 last edit: 2016-06-26T19:25:15+00:00 da Luca

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