Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.
Hepatocellular carcinoma (HCC) accounts for 80% of all liver cancers, and 55% of all HCC cases worldwide are reported from China. In Hong Kong, liver cancer is the fourth most common cancer and the third most common cause of cancer death.
Non-small cell lung cancer (NSCLC) was a key feature of the American Society of Clinical Oncology (ASCO) 2019 annual meeting. This year, exciting results with neoadjuvant immunotherapy (I-O) from the LCMC3, NEOSTAR, and GECP16/03_NADIM studies as well as combinations of I-O and PARP-inhibitors with chemoradiation therapy, and more. A summary of 36 oral presentations on NSCLC, SCLC, and Mesothelioma.
On the 3rd of May 2019, the FDA approved ado-trastuzumab emtansine (Kadcyla® [T-DM1], Genentech/Roche) as adjuvant therapy for human epidermal growth factor receptor (HER2)-positive early breast cancer (EBC) patients with residual invasive disease after neoadjuvant treatment with a taxane and trastuzumab.
Combining programmed death 1 ligand (PD-L1) inhibitor atezolizumab with MEK-inhibitor cobimetinib in patients with previously treated metastatic colorectal cancer (mCRC) does not improve the overall survival (OS) when compared to regorafenib, as was reported by the investigators of the IMblaze370 (NCT02788279) trial in the Lancet Oncology.
On 18 March 2019, the FDA approved atezolizumab (Tecentriq®, Genentech) plus carboplatin and etoposide as front-line treatment of adult extensive-stage small cell lung cancer (ES-SCLC) patients.
On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).
On 28 February 2019, the FDA approved the subcutaneous formulation trastuzumab/hyaluronidase-oysk (Herceptin Hylecta®, Genentech) for the treatment of human epidermal growth factor receptor 2 (HER2)‑overexpressing breast cancer.
On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.
On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.
On 6 December 2018, the FDA approved atezolizumab (Tecentriq®, Roche/Genentech) plus bevacizumab and chemotherapy with paclitaxel and carboplatin for the frontline treatment of metastatic non-squamous non-small cell lung cancer (NSq NSCLC) patients not harbouring any EGFR or ALK genomic tumour aberrations.
On the first day of the 2018 American Society of Hematology (ASH) Annual Meeting, an additional year of follow-up data from the practice-changing MURANO study were presented to the audience by Professor John F. Seymour. In the trial’s setting of relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL), the non-chemo-containing regimen venetoclax (Venclexta®, AbbVie/Roche) plus rituximab was associated with maintained superior progression-free survival (PFS) and overall survival (OS) over standard-of-care chemoimmunotherapy with bendamustine plus rituximab. At the same time, a durable post-treatment disease control is also attainable with the fixed-duration chemo-free regimen.
On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in patients with comorbidities precluding intensive induction chemotherapy.
Relapsing multiple sclerosis (MS) patients initiating ocrelizumab (Ocrevus®, Roche/Genentech) two years earlier had significant reductions in 5-year brain atrophy rates when compared to those switching from interferon β-1a, as reported in the latest results from the OPERA studies’ extension phase.
SUZHOU, China, Oct. 14, 2018 /PRNewswire/ — The combination therapy of novel programmed death 1 (PD-1) antibody IBI308 (sintilimab, Innovent Biologics) with biosimilar bevacizumab antibody IBI305 (Innovent Biologics) has received the investigational new drug (IND) application for clinical development approval by the National Medical Products Administration (NMPA, formerly known as CFDA) in China.
Atezolizumab (Tecentriq®, Roche/Genentech) plus standard chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer (SCLC) was associated with a significantly longer overall survival (OS) and progression-free survival (PFS) when compared with chemotherapy alone.
An interim analysis of the Phase III IMpower132 study showed that atezolizumab (Tecentriq®, Roche/Genentech) plus platinum-based chemotherapy (cisplatin or carboplatin) with pemetrexed improves the median progression-free survival (PFS) in treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). The median PFS for atezolizumab plus pemetrexed and a platinum salt was 7.6 months vs 5.2 months with chemotherapy alone (HR=0.60, 95% CI: 0.49-0.72; p<0.0001).
First-line osimertinib was associated with a clinically meaningful progression-free survival (PFS) improvement when compared to a standard-of-care (SOC) epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in a sub-analysis of Asian patients who participated in the FLAURA trial (NCT02296125).
On the 11th of September 2018, the FDA updated the label of venetoclax tablets (VENCLEXTA®, Abbvie) in combination with rituximab (MabThera®, Roche) to include information about pre-treated patients with chronic lymphocytic leukemia (CLL) in the Phase III MURANO trial who had achieved Minimal Residual Disease (MRD)-negativity.
A high tumour mutational burden in the plasma (bTMB) is a clinically actionable biomarker for atezolizumab (Tencentriq®, Roche) treatment in patients who failed 1st-line platinum-based therapy for advanced non-small cell lung cancer (NSCLC).
On the 16th of August, 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 levels in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.
Non-small cell lung cancer (NSCLC): a key feature of the American Society of Clinical Oncology (ASCO) 2018 annual meeting. This year, encouraging results with single-agent immunotherapy (I-O) and combinations of I-O with chemotherapy (CTx), including the CheckMate 227 with nivolumab (NIVO), IMpower131 and IMpower150 studies with atezolizumab (ATEZO), and KEYNOTE-042 and KEYNOTE-407 studies with pembrolizumab (PEMBRO). Furthermore, important Asian data on treatments for epidermal growth-factor recptor (EGFR) mutation-positive (mu+) NSCLC (ARCHER 1050, NEJ009, NEJ026, and JO25567).
On June 19, the FDA limited the use of atezolizumab and pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-containing therapy.
Breast cancer: a front-runner when it comes to the development of novel therapeutic strategies. With the advent of newer targeted- and immunotherapies, oncologists have an increment of options to offer their patients. The American Society of Clinical Oncology’s (ASCO) 2018 Breast Cancer track offered an extensive look at the latest advancements and updates from on-going trials covering the various subtypes of breast cancer.
- On June 13, 2018, the FDA approved bevacizumab (AvastinⓇ, Genentech, Inc.) in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab for use after surgical resection in patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.
This year’s American Society of Clinical Oncology (ASCO) annual meeting includes two Phase III studies in the second-line treatment of the disease. Moreover, data with several immune-checkpoint inhibitors were presented, including the KEYNOTE-224 with pembrolizumab. Welcome to the summary of the ASCO 2018 HCC track.
On May 18, the United States (US) Food and Drug Administration (FDA) issued an alert about the decreased survival in studies with pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) as single agent first-line therapy for patients with metastatic urothelial cancer (mUCC) and low expression of the programmed death ligand 1 (PD-L1) protein.
First-line atezolizumab plus bevacizumab, carboplatin and paclitaxel improves PFS in patients with non-squamous NSCLC. Two presentations on the IMPower150 study by Martin Reck (ELCC 2018) and Mark Socinski (AACR 2018) discussed the frontline addition of atezolizumab to bevacizumab and chemotherapy in different lung cancer subgroups (NCT02366143).
Tisagenlecleucel CAR-T receives additional FDA Approval for DLBCL
- FDA approved tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.) a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. More Information.
The expansion of therapeutic options with immunotherapies will reflect a dramatic change in the guidelines for lung cancer, where immunotherapies mostly compete with the use of chemotherapeutic agents. A brief communication on immunotherapies for NSCLC.
On 20 December 2017, the FDA granted regular approval to pertuzumab (Perjeta®, Roche/Genentech) for use with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer and a high recurrence risk.
On 1 December 2017, the FDA approved Ogivri® (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin® (trastuzumab, Genentech) for the treatment of patients with HER2-overexpressing breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
There is no excerpt because this is a protected post.
On 16 November 2017, the FDA granted regular approval to obinutuzumab (Gazyva®, Genentech) in combination with chemotherapy, followed by obinutuzumab monotherapy in adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL) patients who achieved at least a partial remission.
On 6 November 2017, the FDA granted regular approval to alectinib (Alecensa®, Roche/Genentech) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
On 6 November 2017, the FDA granted regular approval to vemurafenib (Zelboraf®, Roche) for the treatment of patients with Erdheim-Chester Disease (ECD) harbouring a BRAF V600 mutation.
There is no excerpt because this is a protected post.
There is no excerpt because this is a protected post.