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Roche's subcutaneous Perjeta/Herceptin combo proves non-inferior to IV formulation in HER2-positive early breast cancer

New Phase 3 data from Roche has shown that its subcutaneously-delivered formulation of Perjeta (pertuzumab) and Herceptin (trastuzumab), in combination with intravenous (IV) chemotherapy, proved non-inferior to its standard IV infusion formulation in the treatment of HER2-positive early breast cancer (eBC).

Specifically, the subcutaneous formulation met its primary endpoint, showing non-inferior levels of Perjeta in the blood in addition to comparable efficacy and safety to the standard IV infusion.

Roche's Perjeta secures NICE approval in adjuvant HER2+ metastatic breast cancer

NICE has announced its decision to authorise the use of Roche’s Perjeta (pertuzumab) on the NHS for the treatment of HER2-positive breast cancer after surgery in patients whose disease has spread to their lymph nodes, offering a new treatment option for around 2,700 UK patients.

The decision was based on data showing that the combination of Perjeta, Herceptin and chemotherapy resulted in an increased proportion of patients who did not see their cancer spread.

Scotland recommends Roche's Perjeta for HER2+ metastatic breast cancer

Breast cancer patients in Scotland are set to receive an additional treatment option, as the Scottish Medicines Consortium announces its recommendation for Roche’s Perjeta (pertuzumab) to be used on the NHS for the treatment of HER2-positive metastatic forms of the disease.

The SMC made the judgement based on data from 808 patients illustrating a median progression-free survival rate of 18.5 months with Perjeta compared to 12.4 months in the control group.

NICE turns down Roche's Perjeta for post-surgery HER2-positive breast cancer

Roche’s ongoing dispute with UK health service watchdog NICE over the availability of its monoclonal antibody Perjeta (pertuzumab) on the NHS for the treatment of HER2-positive breast cancer after surgery in patients with high risk of disease recurrence.

EMA's CHMP backs Roche's Perjeta combo in HER2-positive breast cancer

Roche’s Perjeta has edged one step closer to approval as a combo therapy after the EMA’s Committee for Medicinal Products for Human Use (CHMP) backed its use alongside Herceptin (trastuzumab) and chemotherapy in the adjuvant treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence.

NICE approves Perjeta for routine use on NHS

NICE has given the nod to Roche’s Perjeta for routine first-line use, alongside Herceptin and chemotherapy, in patients with HER2-positive breast cancer.

The drug has been available on the Cancer Drug Fund but the successful price negotiations between Roche and NHS England means that all patients will be offered the drug as standard.

The use of Perjeta has been found to increase overall survival, on average, by 16 months, as well as improving the numbers of patients whose cancer did not recur from 90.6% to 92.3%.

FDA grants breast cancer approval to Roche's Perjeta/Herceptin combo therapy

Roche has announced that the FDA has granted approval to Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and a (Perjeta-based) chemotherapy regimen for the adjuvant treatment of HER2-positive early breast cancer which is at a high chance of recurrence.

The FDA based its decision on Phase 3 data which showed that the regimen in question was more effective than Herceptin and chemotherapy alone, cutting the risk of invasive breast cancer recurrence or death by 18%.

NHS England seals access deals with big pharma for breast cancer and MS

NHS England has entered into a commercial agreement with Merck which aims to provide access to innovative treatments for both multiple sclerosis and breast cancer, it has emerged. As part of the agreement with two major pharma firms, Merck’s multiple sclerosis treatment Mavenclad (cladribine tablets) will be made available to hundreds of patients effective 10 November, while an agreement in principle has been reached on the availability of Roche’s Perjeta (pertuzumab) by unlocking the final stage of NICE’s appraisal. 

FDA awards Roche priority review in HER2-positive breast cancer

Roche has revealed that its monoclonal antibody Perjeta (pertuzumab) has been awarded priority review by the FDA as an adjuvant treatment for HER2-positive early breast cancer in combination with Herceptin (trastuzumab) and chemotherapy.

The development means that the FDA has determined that Perjeta offers significant improvement over other treatments, and is expected to make a final approval decision by 28 January 2018. The regulator’s decision was based on Phase 3 trial results of the drug in 4,805 participants.

Roche's neoadjuvant breast cancer combo therapy shows strong Phase 3 results

Roche’s combination treatment of Perjeta (pertuzumab), Herceptin (trasdtuzumab) and chemotherapy met its primary endpoint in a recent Phase 3 study. The therapy improved invasive disease-free survival (iDFS) in those with HER2-positive early breast cancer (eBC) when administered post-surgery, compared to Herceptin and chemotherapy alone.

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