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Roche voluntarily withdraws Tecentriq's US bladder cancer indication

Roche has announced that the company is voluntarily withdrawing the US indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC), also known as bladder cancer.

The company’s decision was made in consultation with the FDA, as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoints and have yet to gain regular approvals.

Roche's Tecentriq fails to hit main Phase 3 goal in front-line ovarian cancer

Roche subsidiary Genentech has revealed that its immunotherapy Tecentriq (atezolizumab), combined with Avastin (bevacizumab), paclitaxel and carboplatin, fell short of its primary endpoint at Phase 3 in the front-line treatment of newly-diagnosed advanced-stage ovarian cancer.

The company admitted that the combo therapy did not meet its main goal of progression-free survival benefit. However, the safety profile of the combo was found to be consistent with previous data.

NICE reverses previous stance to recommend Roche's Tecentriq in extensive-stage small-cell lung cancer

NHS patients with treatment-naïve extensive-stage small-cell lung cancer (ES-SCLC) in England and Wales will soon have access to a new treatment option as NICE reveals it has authorised Roche’s Tecentriq (atezolizumab) in this indication.

The therapy ­has been recommended in combination with carboplatin and etoposide chemotherapy. Around 1,200 patients are expected to benefit from the decision, of the estimated 2,400 with ES-SCLC) in England and Wales.

Roche's Tecentriq falls short as an adjuvant monotherapy in muscle-invasive urothelial cancer

Roche has released an update on the development of its immunology Tecentriq (atezolizumab), making it known that the drug failed to meet its primary endpoint as a monotherapy after surgery for the treatment of muscle-invasive urothelial cancer (MIUC).

The company confirmed that the therapy did not prove sufficient benefit in improving disease-free survival at Phase 3, falling short of its efficacy goal. The drug’s safety profile, however, was found to be positive and consistent with previous data.

Roche's Tecentriq combo boosts progression-free survival in previously untreated BRAF V600 mutation-positive advanced melanoma

Roche has lifted the curtain on new Phase 3 data for its immunotherapy Tecentriq (atezolizumab), confirming that the therapy, when combined with Cotellic (cobimetinib) and Zelboraf (vemurafenib), met its primary endpoint in the treatment of previously untreated BRAF V600 mutation-positive advanced melanoma.

While specifics of the findings were not revealed, Roche confirmed that the combo generated a “significant and clinically meaningful” improvement in progression-free survival (PFS) compared to placebo plus Cotellic and Zelboraf.

Roche's Tecentriq combo scores FDA approval in non-small cell lung cancer

Roche’s immunotherapy Tecentriq (atelizumab) has chalked up another approval from the FDA, this time in combination with the chemotherapy Abraxane (paclitaxel protein-bound; nab-paclitaxel and carboplatin) for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients whose tumours display no EGFR or ALK genomic aberrations.

Phase 3 data submitted in support of the approval showed that the combo produced a median overall survival benefit of 18.6 months compared to 13.9 months with chemo alone in the intention-to-treat wild-type populati

Roche's Tecentriq combo outclasses Nexavar in unresectable hepatocellular carcinoma

Roche has revealed new Phase 3 data for its immunotherapy drug Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) in the treatment of unresectable hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy.

The company announced the findings at the European Society for Medical Oncology (ESMO) Asia Congress 2019 on Saturday.

Roche's Tecentriq/Avastin combo smashes endpoints at Phase 3 in unresectable hepatocellular carcinoma

New Phase 3 data has emerged demonstrating the efficacy of Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) in the treatment of unresectable hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy.

The results, drawn from a trial of 501 unresectable HCC patients, showed that the pair of drugs met the trial’s co-primary endpoints, generating “statistically significant and clinically meaningful improvements” in both overall survival and progression-free survival compared to Nexavar (sorafenib), the current standard of care.

NICE rejects Roche's immunotherapy Tecentriq in unresectable metastatic triple A breast cancer

NICE has revealed its decision not to approve Roche’s immunotherapy Tecentriq (atezolizumab) for use on the NHS in England and Wales for the treatment of unresectable, metastatic triple A breast cancer.

The decision puts the UK watchdog at odds with the FDA and EMA, who both saw fit to approve the drug – their first approved therapy for triple A breast cancer patients. Tecentriq works by blocking PD-L1, and is the first immunotherapy to specifically target tumours which express the protein by 1% or more.

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