News

Two are better than one
Enlarge image

RegulatoryEUDenmarkSwitzerland

Two are better than one

12.06.2012 - FDA approves Roche's antibody pertuzumab (Perjeta). Given together with trastuzumab (Herceptin) it will help breast cancer patients.

Basel/Glostrup/Bethesda – The US Food and Drug Administration (FDA) has approved Roche's drug Perjeta (pertuzumab) as combination therapy of people with metastatic HER2-positive breast cancer who have not received HER2 therapy or chemotherapy before. When administered together with Herceptin (trastuzumab) and in combination with standard docetaxel chemotherapy, Perjeta showed an increase in progression-free survival time of 6.1 months. Data stems from a Phase III study, the treatment of the control group was Herceptin and docetaxel chemotherapy alone.

Both the HER2 signaling inhibitor Herceptin and the HER2 dimerisation blocker Perjeta are humanised monoclonal antibodies. And both target the HER2 receptor, a protein found highly enriched on the outside of cells in a kind of breast cancer aptly named HER2-positive metastatic breast cancer. However, both drugs act in a complementary fashion, meaning that they target different parts of the HER2 receptor.  Currently, Genentech, the manufacturer of Perjeta, is not able to meet demand. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said why the approval was given in spite of the shortage: "There's a need for the treatment of metastatic breast cancer and we do not want to delay the drug's availability to patients pending resolution of the production issues relating to further supply." 

In March, Roche filed an EU market authorisation application for the subcutaneous administration of Herceptin which is less invasive and takes less time.

On 12 June, cancer diagnostics company Dako Denmark A/S announced that the FDA has granted market authroisation for its HercepTestand HER2 FISH pharmDxKit as companion diagnostics for pertuzumab.

http://www.european-biotechnology-news.com/news/news/2012-02/two-are-better-than-one-for-roche-and-for-patients.html

SurveyGermany

06.05.2015 More revenue, more staff, more funding: in the German biotech industry, all signs are pointing towards growth.

M&ASwitzerland

04.05.2015 Swiss crop chemical maker Syngenta AG is in talks with US company Monsanto to discuss a possible merger, insiders say.

BiofuelsEU

30.04.2015 The European Parliament has given the go-ahead on a new law limiting the use of harmful crop-based biofuel in the transport sector. The decision marks a breakthrough in the EU’s approach to biofuels.

FinancingSwitzerlandUK

29.04.2015 Biopharma start-up CRISPR Therapeutics has raised US$64m to hurry the new CRISPR/Cas9 technology to the clinic.

FinancingBelgium

28.04.2015 After having raised €100m in its stock market debut, MDx company Biocartis has gained 13 percent on its first trading day.

Swiss Biotech DaySwitzerland

16.04.2015 The Swiss biotech industry can look back on 2014 as a good year, but political uncertainties do remain. This was one of the topics discussed during the Swiss Biotech Day in Basel, which attracted more than 400 participants.

FinancingUK

21.04.2015 Ahead of its listing on the London Stock Exchange, Woodford’s Patient Capital Trust has raised a record sum of €1.1bn. The fund met with immense interest by investors.

PoliticsEU

22.04.2015 A legislative proposal by the European Commission is set to renationalise market authorisation of genetically modified crops.

EventEUFrance

16.04.2015 The changing landscape in healthcare was just one of the hotly discussed topics of the 27th Annual EuroMeeting of the international association DIA.

R&DFranceUKSweden

24.04.2015 AstraZeneca has boosted its oncology portfolio by signing a US$1.275bn agreement with Innate Pharma. The companies plan to further the development of Innate’s tumour-targeting antibody.

Events

All Events

Partner-Events

München

BioVaria 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC5.41 EUR4.04%
  • WILEX5.25 EUR3.35%
  • BIOFRONTERA2.34 EUR1.74%

FLOP

  • VITA 345.86 EUR-6.69%
  • FORMYCON26.31 EUR-6.04%
  • MORPHOSYS63.42 EUR-6.02%

TOP

  • 4SC5.41 EUR263.1%
  • WILEX5.25 EUR72.1%
  • SARTORIUS148.50 EUR15.7%

FLOP

  • BIOTEST72.00 EUR-24.1%
  • THERAMETRICS0.07 CHF-22.2%
  • MERCK KGAA96.29 EUR-10.9%

TOP

  • SANTHERA96.00 CHF2361.5%
  • CYTOS1.27 CHF807.1%
  • WILEX5.25 EUR510.5%

FLOP

  • MOLOGEN4.85 EUR-55.9%
  • THERAMETRICS0.07 CHF-30.0%
  • BIOFRONTERA2.34 EUR-27.8%

No liability assumed, Date: 06.05.2015