News

Roche’s T-DM1 over next hurdle
Enlarge image

Clinical TrialsEUSwitzerland

Roche’s T-DM1 over next hurdle

28.08.2012 - Swiss Roche AG reports its antibody-drug conjugate trastuzumab emtansine (T-DM1) improves overall breast cancer survival – and files MAAs.

After first promising news in spring Basel-headquartered F. Hoffmann-La Roche AG adds more substantiating Phase III data concerning the benefit of its antibody-drug conjugate (ADC) trastuzumab emtansine (T-DM1). On 27 August, the company and its licence partner ImmunoGen announced that the conjugate not only significantly improved progression-free survival (PFS) but also overall survival (OS) in patients with metastatic breast cancer. Patient data – which will be presented at an upcoming medical meeting – stems from the EMILIA Phase III trial. In EMILIA, the new drug was tested on 991 patients with HER2-positive non-resectable locally advanced or metastatic breast cancer who had previously unsuccessfully received trastuzumab (Herceptin) plus chemotherapy. Enrolled patients either fell into the T-DM1-only group or into the control, standard-of-care group receiving lapatinib (Tykerb) plus capecitabine (Xeloda). Roche also announced that it is about to submit the marketing application for T-DM1 to the European Medicines Agency (EMA).

 Genentech Inc., a Roche subsidiary situated in San Francisco (USA), is the developer of T-DM1. The company has already filed a marketing application for the drug to the Food and Drug Administration (FDA) in the US. The development was accomplished under an agreement with ImmunoGen, Inc. from Waltham (USA). The company from Massachusetts provides the linker chemistry and the compound drug’s cancer killing agent, which is targeted by the antibody (trastuzumab) to Her2neu tumour cell receptors. ImmunoGen calls its technology TAP, Targeted Antibody Payload. The cytotoxic agent is a derivative of maytansine that inhibits the assembly of microtubules. Maytansines are potent toxins that naturally occur in the shrubs and trees of the Genus Maytenus spp.

FundingEU

17.04.2014 The European Parliament has given green light to the second Innovative Medicines Initiative with the aim to advance pharmacological research and development, particularly in areas of unmet medical need.

BusinessGermanyFrance

15.04.2014 German flavour and scent specialist Symrise has announced its plans to acquire French pet-food ingredients maker Diana Group for €1.3bn.

BioeconomySpain

14.04.2014 Spanish Neol Biosolutions and the Center for Second Generation Biofuels are starting a partnership to scale-up Neol's waste-to-oil technology.

EvidenceUKSwitzerland

11.04.2014 There is no evidence that neuraminidase inhibitors Tamiflu and Relenza prevent complications of influenza or reduce hospital admissions. In addition, it is unclear whether they can stop the spread of influenza in case of outbreaks, says a report by the Cochrane Collaboration.

BusinessSwitzerlandSpain

09.04.2014 Roche is extending its involvement in the area of point-of-care diagnostics by taking over US company Iquum. In the field of epigenetics, the Swiss pharma company has started a cooperation with the Spanish company Oryzon.

Status ReportSwitzerland

08.04.2014 The Swiss Biotech Report 2014 presented in Zurich sees an encouraging upturn in the country's biotech scene. However, the acceptance of the mass immigration initiative poses a significant threat.

NanobiotechnologyItaly

07.04.2014 Scientists from the University of Udine have designed, produced and tested a prototype for a "DNA origami" nanorobot that can potentially deliver biological activators in-vivo.

EpidemicEUFranceGermanyItaly

02.04.2014 As the Ebola epidemic in Guinea worsens, Europe is deploying the specialists of EMLab to provide diagnostics at the focus of the outbreak.

BioeconomyFranceEU

01.04.2014 The European Commission has approved a French state package aid worth €43m for green chemistry project IEED.

MonitoringEU

27.03.2014 In Europe, bacterial resistance to prevalent antimicrobials is common, while multi-resistance remains low, EFSA and ECDC now report.

Events

All Events

Partner-Events

München

BioVaria 2014

Frankfurt am Main

7th DVFA Life Science Conference

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MORPHOSYS (D)62.00 EUR11.8%
  • BIOINVENT INTERNATIONAL AB (S)2.96 SEK10.9%
  • BAVARIAN NORDIC (D)14.56 EUR10.3%

FLOP

  • CYTOS (CH)0.17 CHF-26.1%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.3%
  • FLAMEL TECHNOLOGIES (F)9.94 USD-9.7%

TOP

  • CO.DON (D)3.30 EUR90.8%
  • BIOTECH PHARMACON (N)17.50 NOK63.6%
  • WILEX (D)0.92 EUR55.9%

FLOP

  • CYTOS (CH)0.17 CHF-94.0%
  • BIONOR PHARMA (N)2.11 NOK-48.0%
  • GW PHARMACEUTICALS (UK)219.25 GBP-39.8%

TOP

  • SILENCE THERAPEUTICS (UK)256.00 GBP6221.0%
  • IXICO (UK)71.50 GBP791.5%
  • PLETHORA (UK)10.62 GBP585.2%

FLOP

  • CYTOS (CH)0.17 CHF-95.8%
  • EVOCUTIS (UK)0.22 GBP-92.5%
  • AGENNIX (D)0.04 EUR-77.8%

No liability assumed, Date: 17.04.2014