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Roche gets OK for Herceptin-ADC

25.02.2013 - Roche has received the OK to market its breast cancer antibody-drug conjugate T-DM1 in the US under the brand name Kadcyla.

The FDA granted the approval for Kadcyla monotherapy plus Xeloda (capecitabine) of Her2-positive women with metastatic breast cancer, who had already been treated with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is composed of the antibody, trastuzumab which is linked to the chemotherapeutic DM1 and targets the toxin, which kills proliferating cells, to the tumour. 

“Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future.”

Roche currently has eight ADCs in early clinical testing for different types of cancer.  Roche has also submitted a Marketing Authorisation Application to other Regulatory Authorities around the world, including the European Medicines Agency (EMA). The FDA approval of Kadcyla is based on results from EMILIA (TDM4370g/BO21977), an international, Phase III, randomised, open-label study comparing Kadcyla alone to lapatinib – the current standard of care – in combination with Xeloda (capecitabine) in 991 people with HER2-positive locally advanced breast cancer previously been treated with Herceptin and a taxane chemotherapy. The study met both co-primary efficacy endpoints of overall survival and progression-free survival.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/roche-gets-ok-for-herceptin-adc.html

FinancingSpain

04.05.2016 Barcelona-based epigenetics expert Oryzon Genomics has closed a debt funding round of €10.5m, bringing the total money raised since last year to €27m. The funds will serve to advance the company’s two LSD1 inhibitors in cancer and neurodegeneration.

Open InnovationFrance

03.05.2016 Ipsen is strengthening its ties to long-time development partner Oncodesign, a Dijon-based cancer treatment biotech. The French pharma is handing over the pre-clinical pharmacology for its oncology research programmes to Oncodesign.

FinancingSwitzerlandEU

29.04.2016 Swiss bank Group UBS has raised US$471m (€412m) for the UBS Oncology Impact Fund, which was set up to invest in early-stage cancer treatments. The money raised by the fund, nearly half of which comes from investors in Asia, is the largest amount ever raised for such a cancer investment fund.

Industry reportGermany

27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).

Clinical ResearchFrancePortugal

21.04.2016 An expert panel’s final report on the fatal drug trial earlier this year in France states that the death of one of the participants was most likely caused by the drug’s toxicity and not by any violation of the rules.

Immuno-oncologyNetherlandsBelgium

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RegulatorySwitzerlandEU

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Immuno-oncologyUK

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FinancingSwitzerlandFranceEUGermanyDenmark

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Event ReviewSwitzerlandBelgiumEU

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No liability assumed, Date: 04.05.2016