Top Pharma News of the Week

U.S. FDA Approves Pfizer’s Bosulif® (Bosutinib) For the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)

December 19, 2017

Pfizer Inc. has announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The sNDA was reviewed and approved under the FDA’s Priority Review and accelerated approval programs based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial. BOSULIF was first approved in September 2012 in the U.S. for the treatment of adult patients with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease

December 20, 2017

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The purpose of adjuvant therapy is to reduce the risk of recurrence following surgical removal of the tumor and lymph nodes that contain cancer. In the Phase 3 CheckMate -238 trial, Opdivo significantly improved recurrence-free survival (RFS) versus an active comparator, Yervoy (ipilimumab), in patients with stage IIIB/C or stage IV melanoma after surgery. This benefit was observed across important subgroups, including in both BRAF mutant and BRAF wild-type patients. Opdivo is the first and only agent approved for the adjuvant treatment of melanoma based on a head-to-head trial against an active comparator with a proven overall survival benefit.

TARIS and Bristol-Myers Squibb Announce Clinical Trial Collaboration


December 20, 2017

TARIS Biomedical LLC, and Bristol-Myers Squibb have announced that the companies have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS™), in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab). The Phase 1b trial will evaluate the combination in patients with Muscle Invasive Bladder Cancer (MIBC) who are scheduled for radical cystectomy. In conjunction with this collaboration, Bristol-Myers Squibb also made an equity investment in TARIS.

FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer

December 21, 2017

Roche has announced that the US Food and Drug Administration (FDA) has approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC) at high risk of recurrence.1 People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimetres in diameter or node-positive). People receiving the neoadjuvant Perjeta-based regimen should continue Perjeta and Herceptin after surgery to complete one year of treatment.

FDA Grants Breakthrough Therapy Designation for Avelumab In Combination with Inlyta® In Advanced Renal Cell Carcinoma

December 21, 2017

Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA® (axitinib)* for treatment-naïve patients with advanced renal cell carcinoma (RCC). Breakthrough Therapy Designation is designed to accelerate the development and review of potential medicines for serious conditions, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over currently available therapies on one or more clinically significant endpoints. This is the second Breakthrough Therapy Designation granted to avelumab.

Janssen Enters Worldwide Collaboration and License Agreement with Chinese Company Legend Biotech to Develop Investigational CAR-T Anti-Cancer Therapy

December 21, 2017

Janssen Biotech, Inc. has announced that it has entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited (“Legend”), subsidiaries of Genscript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen (BCMA). LCAR-B38M is currently accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the United States for multiple myeloma.


European Commission approves Roche’s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer

December 21, 2017

Roche has announced that the European Commission (EC) has granted a marketing authorization for Alecensa® (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 53% (hazard ratio (HR)=0.47, 95% confidence interval (CI): 0.34-0.65, p<0.001) compared to crizotinib. The study also showed that Alecensa reduced the risk of tumors spreading to, or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10-0.28, p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favorably to crizotinib.

Roche and Ignyta reach definitive merger agreement

December 22, 2017

Roche and Ignyta, Inc. have announced that they have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of US$ 27.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 1.7 billion on a fully diluted basis. This price represents a premium of 74% to Ignyta’s closing price on 21 December 2017 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on 21 December 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.


Novartis drug Tasigna® is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label


December 22, 2017

Novartis has announced that the US Food and Drug Administration (FDA) approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna® (nilotinib) US product label. Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor (TKI) to include data about attempting treatment discontinuation in eligible adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) after achieving sustained deep molecular response of MR4.5 (BCR-ABL1 International Scale [IS] <= 0.0032%) in its FDA-approved prescribing information. TFR is the ability to maintain a sustained molecular response after stopping TKI therapy in patients with Ph+ CML-CP. TFR requires scheduled monitoring of BCR-ABL1 levels to identify possible loss of molecular response.


FDA Approves SGLT2 Inhibitor Steglatro™ (Ertugliflozin) And Fixed-Dose Combination Steglujan™ (Ertugliflozin And Sitagliptin) for Adults with Type 2 Diabetes

December 22, 2017

Merck, known as MSD outside the United States and Canada, and Pfizer Inc., have announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATRO™ (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets.

Top Pharma News of the Week last edit: 2018-01-04T19:27:11+00:00 da Luca

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