Bayer’s cancer drug Xofigo approved, Roche’s Obinutuzumab filled for market approval, and Astrazeneca’s moving foward it’s cancer pipeline to phase III

May 16, 2013 | By Márcio Barra

Cancer drugs had a field day today, with one prostate cancer drug from Bayer approved in the US, one from Roche being filled for marketing approval, and three from Astrazeneca entering phase III.

Xofigo, from Bayer

Xofigo, from Bayer

First up is Bayer’s prostate cancer drug, Xofigo, who received marketing approval from the FDA following a three month priority review, three months ahead of schedule. Xofigo, a radiation pharmaceutical drug based on radium 223, and developed by the Norwegian company Algeta ASA in a partnership with Bayer, was approved for injection in men with symptomatic late-stage castration-resistant prostate cancer that has spread to bones. Xofigo binds to targets in bone tissue due to its chemical similarity to calcium. Alpha radiation is then delivered directly to bone tumors, limiting the damage to healthy nearby tissues.

Xofigo’s approval  was based on data from a Phase III trial that shows men taking Xofigo lived a median of 14 months, compared to 11.2 months for those receiving a placebo. This treatment is currently under review by the European’s Medicines Agency.  Peak sales of one billion are expected by analysts.

Rituxan, from Roche. Obinutuzumab was developed to replace Rituxan, who is set to lose it’s patent.

Next up is Roche, who just filed their chronic lymphocytic leukaemia drug, obinutuzumab, for market approval in Europe, via the EMA, and in the US via the FDA.  The latter has granted obinutuzumab ‘breakthrough therapy designation’

Obinutuzumab can be seen as Roche’s response to Rituxan losing its patent in Europe this year. Obinutuzumab, or  GA101, is an antibody created to improve the immune system’s capability to attack and kill B cells, from which chronic lymphocytic leukemia originates. From the clinical trial data released yesterday, the drug shows marked improvements over Roche’s own Rituxan, due to its increased potency in attacking B cells.

Obinutuzumab was given with the chemotherapy agent chlorambucil to previously untreated patients with chronic lymphocytic leukemia, and compared to people who received only chemotherapy. The results were extremely positive – the combination of Obinutuzumab plus chemotherapy led to an 86 % reduction in risk of disease progression,and patients went 23 months on average before their leukemia began to worsen (progression-free survival), compared with 10.9 months for chemotherapy alone.

Roche’s new medicine, however, has a far higher incidence of neutropenia, or reductions in white blood cell count, than either Rituxan or chemo alone. The safety profile was still deemed acceptabl by Roche since the neutropenia events did not lead to infections or fever. Now it’s up to the agencies to decide.

The drug is currently being tested in a face to face trial against Rituxan.

Lastly, Astrazeneca announced that it moved three cancer drugs into Phase III trials:

  • Moxetumomab pasudotox, a CD22 (a type of molecule found on the surface of B cells) immunotoxin that internalizes in the tumorous cells, causing their death. This drug will be tested as a potential treatment in adults with hairy cell leukaemia who have not responded to or relapsed after standard therapy. It is currently being developed by MedImmune, AstraZeneca’s global biologics research and development arm.
  • Olaparib, a novel agent for platinum-sensitive relapsed ovarian cancer patients with BRCA mutations, which works by exploiting DNA repair pathway deficiencies to kill cancer cells.
  • Selumetinib, a selective MEK kinase inhibitor, for non-small cell lung cancer patients with KRAS mutations.


Online Pharma Times


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