Trastuzumab News and Research

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Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-DM1 BLA

ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

Health Canada approves first targeted biological therapy to show survival benefit in stomach cancer

Roche announced today that after priority review, Health Canada has approved HERCEPTIN(R) (trastuzumab), in combination with XELODA(R) (capecitabine) or intravenous 5-fluorouracil and cisplatin, for the first-line treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach (gastric cancer) or gastro-esophageal cancer.

9 Aug 2010

Incyte second-quarter total revenues increase to $49.8 million

Incyte Corporation today reported second quarter 2010 financial results and described progress for several of its clinical programs.

5 Aug 2010

ImmunoGen fourth-quarter 2010 net loss increases to $13.4 million

ImmunoGen, Inc., a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced financial results for the three-month period and fiscal year ended June 30, 2010.

5 Aug 2010

Infinity reports $18.4 million total revenue for second-quarter 2010

Infinity Pharmaceuticals, Inc., an innovative drug discovery and development company, today detailed recent developments in its product development portfolio and announced second quarter 2010 financial results.

4 Aug 2010

Scientists discover that C35 gene becomes overactive in HER2 positive tumours

UK scientists have discovered that a gene called C35 can work together with other cancer-promoting genes to drive the growth and invasion of breast cancer cells in the lab.

16 Jul 2010

New study on impact of bortezomib on mantle cell lymphoma

A new study by researchers from the John Theurer Cancer Center at Hackensack University Medical Center sheds light on how bortezomib (VELCADE-), the first in a new class of cancer drugs known as proteasome inhibitors, works in mantle cell lymphoma. The study also provides preliminary evidence for which patients might benefit most from bortezomib.

13 Jul 2010

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

Genentech, a member of the Roche Group, today announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.

7 Jul 2010

New presentations on neuroendocrine tumors at ESMO 12th World Congress on Gastrointestinal Cancer

Groundbreaking studies will be presented at the ESMO 12th World Congress on Gastrointestinal Cancer next week in Barcelona, Spain, including exciting new data on treatment for neuroendocrine tumors. "The presentations this year are very significant for clinicians, and outline real progress in the development of agents that are effective in managing and treating gastrointestinal diseases," says Eric Van Cutsem, MD, PhD of the University Hospital Gasthuisberg in Leuven, Belgium and Congress co-chair.

23 Jun 2010

Brazilian breast cancer drug market to grow from $424M in 2009 to $611M in 2014: Decision Resources

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that the breast cancer drug market in Brazil will grow from $424 million in 2009 to $611 million in 2014. Factors promoting the market's growth include steady increases in the number of incident breast cancer cases, shifts toward higher-cost chemotherapy and hormonal regimens in the adjuvant setting and increases in the use of targeted therapies following novel product launches and label extensions.

16 Jun 2010

NICE decides not to recommend lapatinib for women with advanced breast cancer

The National Institute for Health and Clinical Excellence has decided not to recommend the oral drug lapatinib (Tyverb) for women with advanced breast cancer, except for use in clinical trials.

10 Jun 2010

Incyte presents additional results from INCB7839 Phase I/II trial for HER2-positive metastatic breast cancer

Incyte Corporation announced today additional positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 66 patients with HER2-positive metastatic breast cancer during a poster session at the American Society of Clinical Oncology (ASCO) meeting in Chicago, IL, June 4 to June 8, 2010.

7 Jun 2010

Phase Ib/II trial data for trastuzumab-DM1 in combination with pertuzumab presented at ASCO 2010

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of clinical data from a Phase Ib/II trial conducted by Roche and Genentech to investigate the safety and preliminary efficacy of trastuzumab-DM1 (T-DM1) used in combination with Roche's investigational antibody, pertuzumab.

7 Jun 2010

Multiple study data on Agendia's MammaPrint, BluePrint, and ColoPrint assays to be presented at 2010 ASCO

Agendia, a world leader in molecular cancer diagnostics, today announced that researchers from Agendia and leading academic centers in the U.S. and Europe will present data from multiple studies concerning Agendia's assays MammaPrint(R), BluePrint(TM), and ColoPrint(TM) at the American Society of Clinical Oncology Annual Meeting, June 4 - 8, 2010, at McCormick Place in Chicago. MammaPrint, the company's lead product, is the only FDA-cleared breast cancer recurrence test.

5 Jun 2010

Infinity announces Phase 2 clinical trial results of IPI-504 for NSCLC

Infinity Pharmaceuticals, Inc. today reported the results from its Phase 2 clinical trial of IPI-504, the company's i.v.-administered Hsp90 chaperone inhibitor, in patients with advanced non-small cell lung cancer (NSCLC). Data reported show that IPI-504 demonstrated clinical activity in patients with NSCLC, in particular among patients with oncogenic anaplastic lymphoma kinase (ALK) gene rearrangements.

4 Jun 2010

ImmunoGen to present clinical data on IMGN388 solid tumor compound at 2010 ASCO

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that there will be several clinical data presentations for compounds utilizing the Company's Targeted Antibody Payload (TAP) technology at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago on June 4-8, 2010.

25 May 2010

Genentech to present new data for targeted cancer medicines at 46th ASCO

Genentech, Inc., a wholly owned member of the Roche Group, today announced that it will present new data for its targeted cancer medicines and the way they may be used in several different cancer types at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Approximately 400 abstracts featuring Genentech and Roche's cancer medicines and investigational agents across 30 cancer types will be presented during the meeting that is taking place June 4 to 8, 2010 in Chicago.

21 May 2010

Cyclacel Pharmaceuticals reports net loss of $5.1M for first-quarter 2010

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today reported its financial results and business highlights for the first quarter ended March 31, 2010.

14 May 2010

GTC Biotherapeutics reports lower total net loss of $7.7M for first-quarter 2010

GTC Biotherapeutics, Inc. today reported its financial results for the first fiscal quarter ended April 4, 2010. The total net loss for the first quarter was $7.7 million, or $0.26 per share, compared to $10.4 million, or $0.99 per share, for the first quarter of 2009.

12 May 2010