The combination therapy is the first FDA-approved regimen for breast cancer to include immunotherapy. Atezolizumab is the drug’s generic (non-branded) name. This review is to summarize many ongoing phase II/III trials of atezolizumab, durvalumab, avelumab, and new PD-L1 inhibitors in clinical developments. Tecentriq FDA Approval History. FDA Approved: Yes (First approved May 18, 2016) Brand name: Tecentriq Generic name: atezolizumab Dosage form: Injection Company: Genentech, Inc. Treatment for: Bladder Cancer, Non-Small Cell Lung Cancer, Breast Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Melanoma, Metastatic Atezolizumab is the generic name for the trade drug name Tecentriq™. Product Atezolizumab EAMS indication Atezolizumab, in combination with bevacizumab, is indicated for the treatment of adult patients with a cancer that affects the liver called hepatocellular carcinoma (HCC), which cannot be treated by removing the affected portion of the liver and when no other specific medicines have been given for this cancer. TECENTRIQ can cause immune-mediated nephritis. Aetna considers atezolizumab experimental and investigational if disease progresses while on prior anti-PD-1 therapy (e.g., nivolumab (Opdivo), avelumab (Bavencio), pembrolizumab (Keytruda), and durvalumab (Imfinzi)). Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with advanced urothelial carcinoma and patients with metastatic non-small cell lung cancer (NSCLC). Tecentriq is administered via intravenous infusion over 60 minutes every 3 weeks. 1. Melanoma who: • Have BRAF V600 mutation-positive unresectable or metastatic disease, and are receiving atezolizumab in combination with cobimetinib and vemurafenib. Description: Atezolizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody which binds to programmed death ligand 1 (PD-L1) and selectively prevents the interaction between PD-1 and B7.1 (also known as CD80) receptors found on T-cells and antigen presenting cells, releasing PD-L1/PD-1 mediated inhibition of immune response thereby enhancing the immune response to tumour cells. NICE TA492 Atezolizumab (Tecentriq®) is recommended for use within the Cancer Drugs Fund as an option for untreated locally advanced or metastatic urothelial carcinoma in adults, for whom cisplatin-based chemotherapy is unsuitable, only if: their tumours express PD-L1 at a level of 5% or more, and All Indications: 84 billable units every 14 days III. Immunotherapy for treatment of cancer helps the immune system to recognise and attack cancer cells. *Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology. DETAILED DESCRIPTION ... for any known indication is prohibited due to interaction with study medication. Atezolizumab treatment can result in severe and fatal immune-mediated colitis or diarrhea requiring the use of corticosteroids. Basel, 8 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company is voluntarily withdrawing the US indication for Tecentriq® (atezolizumab) in … Atezolizumab already has 4 indications in NSCLC in addition to indications in extensive-stage small cell lung cancer, among other indications. Atezolizumab’s new indication in combination with protein-bound paclitaxel for TNBC in patients who have not received prior chemotherapy for metastatic disease was evaluated in IMpassion130, a multicenter, international, randomized, double-blinded placebo-controlled trial. Pharmaceutical company. The claimed indication of atezolizumab in UC was supported by the clinical trials IMvigor 210 (GO29293) and IMvigor 211 (Study GO29294). 2.3 The list price of atezolizumab is £3,807.69 per 20-ml vial (for the 1,200 mg dose; excluding VAT; BNF online accessed March 2021). The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, a type of protein designed to attach to a protein called PD-L1, which is present on many cancer cells.. PD-L1 acts to switch off immune cells that would otherwise attack cancer cells. This is the ... of an extension of indications. The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, a type of protein designed to attach to a protein called PD-L1, which is present on many cancer cells.. PD-L1 acts to switch off immune cells that would otherwise attack cancer cells. Listing a study does not mean … TECENTRIQ (atezolizumab) injection, for intravenous use Initial U.S. Approval: 2016 RECENT MAJOR CHANGES Indications and Usage, Urothelial Carcinoma – Accelerated Approval Indication Removed (1.1) 4/2021 Indications and Usage, Non-Small Cell Lung Cancer (1.2) 5/2020 Indications and Usage, Triple-Negative Breast Cancer (1.3) 12/2020 Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. ... Atezolizumab … Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC): The case of atezolizumab frustrated even those ODAC panelists who voted to keep its indication in metastatic TNBC, with several citing the factor that helped the drug win the indication … *Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed deathligand 1 (PD- -L1) ... 4.1 Therapeutic indications . May 14, 2020. The effect of atezolizumab allows anti-tumor T cells to remain activated, proliferate, produce cytokines, and kill tumor cells. Based on FDA Review, Manufacturer Withdraws Atezolizumab for Use in Bladder Cancer. Implications for Practice Indications: Locally advanced or Metastatic Urothelial Carcinoma. Immune-related AEs affected 41.4% of patients in the TECENTRIQ + carbo/etop arm vs 24.5% receiving placebo. Drug Type: Atezolizumab is an Anti-PD-L1 monoclonal antibody. Atezolizumab is a humanized IgG1 monoclonal antibody immune checkpoint inhibitor that binds to programmed death-ligand 1 (PD -L1) and blocks its interaction with PD-1 and B7-1 receptors on T -cells. Extended Description. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving Tecentriq® (July 2018) Recommended with restrictions. In February 2021 AstraZeneca announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. Furthermore, the combination of immune checkpoint inhibitors with chemotherapy, an established standard of care in untreated patients with advanced non–small cell lung cancer, adds more complexity to this field. Atezolizumab. Genentech has voluntarily withdrawn the US indication of atezolizumab for the treatment of patients with metastatic urothelial cancer previously treated with platinum-based therapies, according to a press release issued by the company.. Atezolizumab, an intravenously administered monoclonal antibody, received accelerated approval from the US Food and Drug Administration (FDA), which … It was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer in combination with carboplatin and etoposide, according to the press release. New indication concerns first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression. Atezolizumab-bevacizumab was associated with a longer OS and PFS when compared to sorafenib. Efficacy After a median follow up of 8.6 months 28.6% of patients in the atezolizumab–bevacizumab group and 39.4% in the sorafenib group had died (stratified hazard ratio for death, 0.58; 95% confidence interval [CI], 0.42 to 0.79; P<0.001). Use of Atezolizumab (Tecentriq) may be considered medically necessary for clinical indications The new indication for atezolizumab, a PD-L1 inhibitor, as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, provides a new immunotherapy option for patients, regardless of PD-L1 expression. Atezolizumab generic Atezolizumab is a programmed death ligand 1 (PD-L1) monoclonal antibody. The generally accepted state of medical knowledge on which the GB-A findings are For the present indication of Atezolizumab in combination with bevacizumab, the following decision of the G-BA for drug applications is available: • Lenvatinib – Resolution of 22 March 2019 on 4. Atezolizumab (Tecentriq®) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients should be monitored for clinical signs and symptoms of endocrinopathies. Metastatic Non-small cell Lung Cancer. TECENTRIQ Injection for intravenous use is a sterile, preservative-free, colorless to slightly yellow solution in single-dose vials. Atezolizumab is an Fc-engineered, humanized, non-glycosylated IgG1 kappa immunoglobulin that has a calculated molecular mass of 145 kDa. Help your patients pay for their Tecentriq prescriptionGenentech Patient Resource Center Our center dedicated to getting patients and caregivers to the right resources. chemotherapy, and are receiving atezolizumab in combination with bevacizumab; OR 7. The FDA granted accelerated approval to atezolizumab (Tecentriq, Genentech) — an anti-PD-L1 monoclonal antibody — for this indication in 2016 based on results of the IMvigor210 study. clinically indicated. Healthcare professionals are asked to report any suspected adverse events at . Atezolizumab is used with bevacizumab in patients who have not received systemic therapy. The indications for atezolizumab and pembrolizumab in patients who have received prior platinum-based therapy have not been changed. The FDA will reassess 6 indications for immune checkpoint inhibitors that were granted accelerated approval but failed to prove clinical benefit in confirmatory trials. Atezolizumab is an Fc-engineered humanized immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and blocks interactions with the PD-1 and B7.1 receptors, releasing PD-L1 / PD-1 pathway-mediated inhibition of the immune response, including reactivating the … Original therapeutic expiry date: 03/2022. The company has a commercial arrangement.This makes atezolizumab available to the NHS with a discount. (a te zoe LIZ ue mab) Trade Name: Tecentriq™. By: JNCCN 360 Staff Posted: Wednesday, March 10, 2021. On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of … Atezolizumab injection comes as liquid to be injected into a vein over 30 to 60 minutes by a doctor or nurse in a hospital or medical facility. Atezolizumab (Tecentriq) is being voluntarily withdrawn from the US market by Roche for its indication as a treatment for patients with prior-platinum treated metastatic urothelial carcinoma (mUC), according to a press release by the company. Its brand name is Tecentriq. In April 2017, atezolizumab was granted accelerated approval for this indication based on the achievement of durable responses in patients with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (UC) treated with 1200 mg of the agent in the phase 3 … The observed safety profile was consistent with that observed in previous studies of atezolizumab monotherapy across indications, histologic type, and lines of therapy. In addition to the IMpower010 study, the drug is also being studied across a variety of cancer types and settings. However, discussion of these indications is outside the scope of this review. A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. EMA Recommends Extension of Indications for Atezolizumab. This article summarizes the FDA thought process and data supporting the accelerated approval of both agents and the subsequent revision of the indications. Atezolizumab is is a programmed cell death ligand 1 (PD-L1) blocking antibody. On 17 September 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product atezolizumab (Tecentriq). Atezolizumab + Bevacizumab for Hepatocellular Carcinoma. Manufacturer advises patients should be counselled on the effects on driving and performance of skilled tasks—increased risk of drowsiness. Atezolizumab (Tecentriq®) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Learn more about administering TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) as a combination immunotherapy for the treatment of hepatocelluar carcinoma (HCC), a type of liver cancer. On March 8, Genentech, a member of the Roche Group, has announced it will voluntarily withdraw the U.S. indication for atezolizumab (Tecentriq) in patients with metastatic urothelial carcinoma who had received prior platinum therapy. In particular, we focus on key trials that paved the pathway to FDA-approved indications for atezolizumab, durvalumab, and avelumab. In some cases, health care professionals may use the generic name atezolizumab when referring to the trade drug name Tecentriq™. Atezolizumab has shown clinically meaningful benefit in several types of lung cancer, with 5 FDA-approved indications. Melanoma who: • Have BRAF V600 mutation-positive unresectable or metastatic disease, and are receiving atezolizumab in combination with cobimetinib and vemurafenib. Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. The combination was granted accelerated approval for this indication last year. Immunotherapy for treatment of cancer helps the immune system to recognise and attack cancer cells. 2 However, an FDA accelerated approval is contingent upon the results of a confirmatory trial, and in May 2017, Roche reported that the phase 3 IMvigor211 study exploring atezolizumab in the second-line setting for patients with locally advanced … Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab. TECENTRIQ (atezolizumab) injection for intravenous use is a sterile, preservative-free, colorless to slightly yellow solution in single-dose vials. Indication: In combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. Atezolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or … Petros … Atezolizumab is used with paclitaxel albumin-stabilized nanoparticle formulation in adults whose cancer has spread or cannot be removed by surgery .¹. TECENTRIQ is a prescription medicine used to treat adults with: A type of bladder and urinary tract cancer called urothelial carcinoma. Initial Approval Criteria1,4-8,10-14 ... atezolizumab or durvalumab at the time relapse (NOTE: If relapse occurred >6 months after atezolizumab or durvalumab maintenance therapy, patient should be re-treated with Indications Atezolizumab is indicated for the treatment of patients 18 years of age or older with: • Locally advanced or metastatic urothelial carcinoma who: – Have disease progression during or following platinum-containing chemotherapy – Have disease progression within 12 months of neoadjuvant or adjuvant treatment EMA Recommends Extension of Indications for Atezolizumab. After dilution (see section 6.6), the final concentration of the diluted solution should be between 3.2 and 16.8 mg/mL. atezolizumab (Tecentriq) SMC ID: SMC2267. IMvigor 210 (GO29293) This was a multicentre single-arm phase II study in patients with locally advanced or metastatic UC. Our products are for research use only. Atezolizumab is the drug’s generic (non-branded) name. ... Atezolizumab … Date: 29 Mar 2021. [Atezolizumab (Tecentriq ®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma] Treatments for patients with metastatic or advanced urothelial carcinomas on progression after first line chemotherapy or unfit for cisplatin are currently limited. Urothelial carcinoma . Atezolizumab (Tecentriq®) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. The hearings, which are scheduled to be conducted virtually and broadcast via live webcast, will involve 2 indications for atezolizumab (Tecentriq), … The safety profile of atezolizumab was consistent with prior experience of atezolizumab monotherapy across indications and lines of therapy. Coverage Limitations Hepatocellular carcinoma (a type of liver cancer) that is metastatic or cannot be removed by surgery. chemotherapy, and are receiving atezolizumab in combination with bevacizumab; OR 7. Atezolizumab is an anti–PD-L1 monoclonal antibody which is approved in the United States as therapy for certain indications in non–small cell lung cancer, metastatic triple-negative breast cancer, and hepatocellular carcinoma, small cell lung cancer, and melanoma. The specific indication is for atezolizumab use as part of a combination with nab-paclitaxel for patients with unresectable locally advanced … This will allow quick identification of new safety information. (atezolizumab) injection, for intravenous use Initial U.S. Approval: 2016 . One 20 mL vial of concentrate contains 1,200 mg atezolizumab*. Use of Atezolizumab (Tecentriq) may be considered medically necessary for clinical indications Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving Tecentriq® (July 2018) Recommended with restrictions. Topics: Cancer Immunology and Immunotherapy; Lung and other thoracic tumours. Quantity per vial 12 mg. Batch Number B0006B01. Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis and type 1 diabetes mellitus, including diabetic ketoacidosis have been observed in clinical trials with atezolizumab (see section 4.8). Monitor patients for signs and symptoms of enterocolitis (diarrhea, abdominal pain, and mucus or blood in stool) and bowel perforation (peritoneal signs and ileus). The US Food and Drug Administration (FDA) granted Tecentriq (atezolizumab) accelerated approval for this indication based on the results from the IMvigor210 study. DOI: 10.1056/NEJMdo005748. Atezolizumab is an Fc-engineered, humanized, non-glycosylated IgG1 kappa immunoglobulin that has a calculated molecular mass of 145 kDa. Review of Indications of FDA-Approved Immune Checkpoint Inhibitors per NCCN Guidelines with the Level of Evidence ... pembrolizumab, cemiplimab and PD-L1 inhibitors atezolizumab, avelumab, and durvalumab are in the current list of the approved agents in addition to ipilimumab. Atezolizumab is a targeted (biological) therapy. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity. Locally Advanced or Metastatic Triple-Negative Breast Cancer. The Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab; Genentech) as a first-line treatment for adults with metastatic non-small cell … See full safety for more information. It’s also referred to as an immunotherapy. The safety profile of atezolizumab was consistent with prior experience of atezolizumab monotherapy across indications and lines of therapy. Atezolizumab received an accelerated approval from the FDA for this indication in May 2016 based on cohort data from the phase 2 IMvigor210 study. Adrenal insufficiency occurred in 0.4% (11/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions. 1.1 Atezolizumab with nab‑paclitaxel is recommended, within its marketing authorisation, for treating triple-negative, unresectable, locally advanced or metastatic breast cancer in adults whose tumours express PD‑L1 at a level of 1% or more and who have not had previous chemotherapy for metastatic disease. AusPAR Tecentriq atezolizumab Roche Products Pty Ltd PM-2019-00505-1-4 Final 4 June 2020. It is the company's responsibility to let relevant NHS organisations know details of the … This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity. The IMvigor130 study, which is the designated postmarketing requirement study for atezolizumab’s frontline indication, randomized patients with locally advanced or mUC to atezolizumab monotherapy, atezolizumab plus platinum-based chemotherapy, or placebo plus platinum-based chemotherapy. Atezolizumab is the only immune checkpoint inhibitor with an expanded analysis of ADAs but the clinical implication data is conflicting. Aetna considers atezolizumab experimental and investigational for all other indications including the following (not an all-inclusive list) due to insufficient evidence in the peer-reviewed literature: 1. [see Dosage and Administration (2.3)]. r In March 2021, Genentech announced the voluntary withdrawals of Tecentriq® (atezolizumab) for the treatment of prior-platinum treated metastatic urothelial carcinoma. Immune-mediated nephritis with renal dysfunction occurred in <0.1% (1/2616) of patients receiving TECENTRIQ as a single agent, and this adverse reaction was a Grade 3 (<0.1%) adverse reaction. It acts by activating the anti-tumor immune response and is … The three most common AEs for patients taking either TECENTRIQ + carbo/etop or placebo were anaemia, neutropenia and alopecia (all grades) 1,3. Indication. The size of the discount is commercial in confidence. This extended to only those TNBC patients whose tumors expressed PD-L1, which comprised 40 percent of the population enrolled in the study leading to approval.. A multicenter study led by Vandana Abramson, M.D., … Each immune-related AE at grade 3–4 affected ≤2.0% of patients 2. It’s also referred to as an immunotherapy. Atezolizumab, a checkpoint inhibitor that reverses T cell inhibition by blocking PD-L1, was FDA-approved last year for the treatment of triple-negative breast cancer (TNBC). Atezolizumab, as monotherapy or as a component of combination therapy, is also approved for use in the treatment of advanced urothelial carcinoma, NSCLC, triple-negative breast cancer or hepatocellular carcinoma (e.g. Atezolizumab is an Fc-engineered, humanized, non-glycosylated IgG1 kappa immunoglobulin that has a calculated molecular mass of 145 kDa. Atezolizumab is a targeted (biological) therapy. The FDA will reassess 6 indications for immune checkpoint inhibitors that were granted accelerated approval but failed to prove clinical benefit in confirmatory trials. Roche has withdrawn atezolizumab (Tecentriq) from the US market for the treatment of patients with metastatic urothelial carcinoma who had … Storage Temperature 2-8°C / -80°C. Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), heptatocellular carcinoma and melanoma. Atezolizumab (TECENTRIQ®) Injection for intravenous use is a sterile, preservative-free, colorless to slightly yellow solution in single-dose vials. Its brand name is Tecentriq. Withhold or permanently discontinue TECENTRIQ depending on severity. On March 8, the Food and Drug Administration (FDA) granted an accelerated approval for the immunotherapy drug atezolizumab (Tecentriq) in combination with chemotherapy for the initial treatment of some women with advanced triple-negative breast cancer.. TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Nephritis led to permanent discontinuation of … The “therapeutic expiration date” implies expiry date for patient adminstration and is not applicable to the shelf life of the aliquot. o Atezolizumab 1200 mg, followed by 15 mg/kg bevacizumab, on the same day every 3 weeks o If bevacizumab is discontinued, administer Atezolizumab as: All indications: • Atezolizumab will be approved through clinical review for up to a 6-month duration. in the EU and/or USA) [12, 13]. 2.3 ) ] have BRAF V600 mutation-positive unresectable or metastatic disease, and kill tumor cells atezolizumab indications profile atezolizumab. And other thoracic tumours in the EU and/or USA ) [ 12, ]... The tecentriq + carbo/etop arm vs 24.5 % receiving placebo... for any known indication is prohibited due interaction! Safety information immunotherapy ; lung and other thoracic tumours therapy have not been changed review, manufacturer Withdraws atezolizumab use. 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