The Josh of Roche is high in March 2019 as it gets six approvals for its products during the first half of the month
FDA approval of Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC)
FDA approved its product Tecentriq (atezolizumab) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy (carboplatin and etoposide) as a first line therapy. The FDA approval is based on company’s Phase-III IMpower133 study, in which Tecentriq (in combination with the chemotherapy) significantly increased in the overall survival rate compared to chemotherapy alone (median overall survival [OS]=12.3 months versus 10.3 months). The combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared to chemotherapy alone (PFS=5.2 months versus 4.3 months).
In USA, Tecentriq is already approved in combination with Avastin (bevacizumab), paclitaxel, and carboplatin as a 1st line therapy for patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. In Europe, Tecentriq and Avastin combination is approved to treat patients with advanced non-squamous NSCLC, including patients with EGFR mutant or ALK genomic tumour aberrations after failure of appropriate targeted therapies.
European approval of MabThera (rituximab) for a rare autoimmune - pemphigus vulgaris (PV)
The European Commission approved MabThera (rituximab) for a rare autoimmune disease known as pemphigus vulgaris (PV) making it the first biologic approved to treat moderate to severe cases of pemphigus vulgaris (PV) in more than 60 years. This approval means that the Mabthera is now approved for four immunology indications in Europe like the US. In June last year, US FDA approved it for the same indication in the US. There are more than 50,000 patients with PV in Europe and this approval provides all of them a new treatment option. The approval in Europe is based on the company’s Phase-III Ritux-3 trial data.
European approval of Hemlibra (emicizumab) for patients with severe haemophilia A without factor VIII inhibitors
The company got the approval for its drug Hemlibra (emicizumab) for patients with severe haemophilia A without factor VIII inhibitors in Europe. Hemilbra significantly reduce treated bleeds compared to prior factor VIII prophylaxis treatments available, and it can be administered subcutaneously, to all age groups, and with multiple dosing options of once weekly, every two weeks, or every four weeks. The approval is based on its pivotal HAVEN-3 and HAVEN-4 studies. It is to be noted that the medicine Hemilbra is already providing tough competition to other treatment options such as recombinant and plasma-derived products in various markets since it is available in more than 60 countries globally.
FDA approval of its Ventana PD-L1 Assay
The company’s Ventana PD-L1 (SP142) Assay has been approved by the US FDA making it the first companion diagnostic to identify triple-negative breast cancer patients eligible for treatm ent with Tecentriq (atezolizumab) in combination with Abraxane. The target assay was used in the IMpassion130 trial, the first positive Phase-III immunotherapy regimen study in triple-negative breast cancer. Globally, around 300,000 women are diagnosed annually with triple-negative breast cancer, an aggressive disease with limited treatment options that represents 15% of all breast cancer cases.
FDA approval of Tecentriq (atezolizumab) plus Abraxane for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC) in patients expressing PD-L1
The company got an accelerated US FDA approval to Tecentriq (atezolizumab) + Abraxane for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumours express PD-L1, as determined by an FDA-approved test. The approval comes basis the clinical data from the Phase III IMpassion130 study, which showed that Tecentriq + Abraxane combination significantly reduced the risk of disease worsening or death (PFS) by 40% compared with Abraxane alone (median PFS=7.4 months versus 4.8 months).
European Marketing Authorisation of Tecentriq in combination with Avastin (bevacizumab), paclitaxel, and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC)
On March 8, the company received European marketing authorisation to approval to its therapy Tecentriq in combination with Avastin (bevacizumab), paclitaxel, and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is specified only after failure of appropriate targeted therapies. The approval comes based on a Phase-III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy significantly increased the overall survival rate as compared to Avastin and chemotherapy (median overall survival [OS]=19.8 months versus 14.9 months)
- Vivek Sharma,