Anticoagulation, which is often provided for atrial fibrillation (AF), decreases the risk of bioprosthetic valve dysfunction (BVD) after transcatheter aortic valve replacement (TAVR), according to the results of the FRANCE-TAVI registry study. Male gender, chronic kidney disease (CKD), and atrial fibrillation (AF) have the highest impact on the 3-year mortality due to BVD after TAVR.
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Camrelizumab (SHR-1210, Hengrui Medicine), a novel programmed death 1 (PD-1) inhibitor, plus gemcitabine and cisplatin showed a manageable toxicity profile with promising, preliminary anti-tumour activity in treatment-naïve Chinese nasopharyngeal carcinoma (NPC) patients. Larger, randomised controlled trials may provide further insight into the role of anti-PD1 for NPC, wrote the authors in the Lancet Oncology.
On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti®, AstraZeneca) for adult patients with relapsed or refractory (R/R) hairy cell leukaemia (HCL) who had received at minimum two prior systemic therapies, of which one a purine nucleoside analogue (PNA).
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.
TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018 -- The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.
The combination capmatinib (INC280, Novartis) plus gefitinib (Iressa®, AstraZeneca) showed promising, early phase efficacy in patients with mesenchymal-epithelial transition factor (MET)-dysregulated and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
CARsgen Therapeutics, a Shanghai-based clinical-stage immune-oncology company committed to developing Chimeric Antigen Receptor T (CAR-T) cell therapies for cancer, presented preliminary data of their first-in-class CAR-Claudin18.2 T-cell clinical trial in pancreatic and gastric cancer patients during the 2018 CAR-TCR Summit in Boston.
SAN FRANCISCO and SHANGHAI, Sept. 6, 2018/PRNewswire/ -- Today, Driver, a global technology platform that connects cancer patients to the best treatments, launches in the United States and China. Driver's platform enables any patient, anywhere in the world, to access treatment options across an unprecedented network of cancer centres without leaving home.
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).
Real-life use of edoxaban (Lixiana®, Daiichi Sankyo) in Asian atrial fibrillation (AF) patients significantly lowered the risk of ischaemic stroke (IS), intracranial haemorrhage (ICH), hospitalisation for gastrointestinal (GI) bleeding, hospitalisation for major bleeding, and all-cause death when compared to warfarin. This was concluded by the Korean investigators in the Journal of the American College of Cardiology. The benefits were consistent in the various high-risk subgroups.
Febuxostat to decrease uric acid levels and aid the prevention of cerebral, cardiovascular and renal events in elderly hyperuricaemia patients as reported by the investigators of the FREED trial during the ESC 2018 Congress.
Biosceptre has announced the initiation of its Phase 1 clinical study with the peptide vaccine BIL06v. BIL06v is a peptide-protein conjugate that recruits the patient's immune system to make antibodies specifically targeted at nfP2X7-expressing cancer cells resulting in tumour cell death.
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.
On the 16th of August 2018, the FDA granted accelerated approval to nivolumab (Opdivo®, Bristol-Myers Squibb) for use in patients with metastatic small cell lung cancer (SCLC) who progressed after two lines of therapy, including one line of platinum-based chemotherapy.
On 20th of August 2018, the FDA granted regular approval for pembrolizumab (Keytruda®, Merck) plus pemetrexed and a platinum salt in the first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSCLC), not harbouring any EGFR or ALK genomic tumour aberrations.
Single-agent PARP-inhibition with talazoparib is associated with an improved progression-free survival (PFS) and better patient-reported outcomes (PRO) when compared to chemotherapy alone in patients with advanced breast cancer (ABC) and a germline BRCA1/2 mutation, as reported by the investigators of the Phase III EMBRACA study (NCT01945775) in the New England Journal of Medicine.
Immunotherapy with either nivolumab (Opdivo®, Bristol-Myers Squibb) alone or the combination nivolumab plus ipilimumab (Yervoy®, Bristol-Myers Squibb) in patients with chemotherapy-refractory esophagogastric cancer leads to durable responses and encouraging long-term overall survival with a manageable safety profile, concluded the investigators of the CheckMate 032 study.
On August 16, 2018 the FDA approved lenvatinib (Lenvima®, Eisai) for the first-line treatment of hepatocellular carcinoma (HCC) patients not amenable for curative surgery.
HONG KONG, August 15, 2018 /PRNewswire/ -- A group of researchers from the Hong Kong Polytechnic University (PolyU) in close collaboration with Sichuan University have successfully designed and manufactured a novel bone scaffold that can be safely implanted into bone defects, induce bone-regeneration, and enhance the recovery of bone injuries and fractures.
HONG KONG, CHINA - 13 August 2018 - Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), announced that its innovative in-house developed oncology drug pirotinib has commenced into Phase II Clinical testing in China following the completion of a Phase I clinical trial in three renowned cancer research centres in the United States.
On the 8th of August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin), a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, for use in adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
On the 31st of July 2018, the FDA approved lusutrombopag (Mulpleta®, Shionogi) for thrombocytopenia in adult chronic liver disease (CLD) patients scheduled for an invasive medical or dental procedure.
On July 30, 2018, the FDA approved iobenguane I-131 (Azedra®, Progenics Pharmaceuticals), a radioactive therapeutic agent, for the treatment of adult and paediatric patients ≥12 years with iobenguane scan positive, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) not amenable to surgery and indicated for systemic therapy.
Osimertinib is active in the second-line treatment of patients with T790M-positive advanced non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases, as reported by the investigators of the Phase III AURA3 study.
In Asian atrial fibrillation (AF) patients, low-dose rivaroxaban (Xarelto®, Bayer) has a similar effect on the risk of thromboembolism and bleeding but not on myocardial infarction (MI) when compared to the standard-dose, as shown in a retrospective population-based cohort study from Taiwan.
Programmed death 1 (PD-1) inhibition with the novel human anti-PD1 monoclonal antibody cemiplimab (REGN2810, Regeneron and Sanofi) in patients with locally advanced or metastatic cutaneous squamous-cell carcinoma (CSCC) resulted in a response in approximately half of the patients.
On July 20, 2018, the US FDA approved ivosidenib (Tibsovo©, Agios Pharmaceuticals) for use in adult patients with relapsed or refractory acute myeloid leukaemia (AML) harbouring a susceptible IDH1 mutation as detected by an FDA-approved companion diagnostic (CDx) test, the Abbott RealTime IDH1 Assay.
On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.
On July 18, 2018, the US FDA expanded the ribociclib (Kysqali©, Novartis) approval. Ribociclib plus an aromatase inhibitor as initial endocrine-based therapy is no longer limited to postmenopausal HR-positive, HER2-negative advanced or metastatic breast cancer patients alone and now includes pre- and perimenopausal women. Furthermore, the FDA has added the combination ribociclib plus fulvestrant as initial endocrine-based therapy for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.
On July 13, the FDA approved enzalutamide (Xtandi©, Astellas), for use in patients with castration-resistant prostate cancer (CRPC).
Metastatic gastric cancer (mGC) patients with microsatellite instability-high (MSI-H) or Epstein-Barr virus (EBV)-positive tumours, or those with a positive (≥1%) combined positive score (CPS) respond best to pembrolizumab PD-1 immunotherapy.
On July 10th, the FDA granted accelerated approval to ipilimumab (Yervoy©, Bristol-Myers Squibb) for use in combination with nivolumab (Opdivo©) for the treatment of adult and paediatric patients ≥12 years of age with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
On June 27th, the FDA approved Array Biomarpharma's combination encorafenib (BRAFTOVI®) plus binimetinib (and MEKTOVI®) for patients with unresectable or metastatic melanoma harbouring a BRAF V600E or V600K mutation detected by an FDA-approved test.
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.
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.
On June 13, 2018, the US FDA has granted accelerated approval to pembrolizumab (Keytruda, Merck & Co) for the treatment of adult and pediatric patients with primary mediastinal large B-cell lymphoma (PMBCL), relapsed after two or more prior lines of prior therapy.
On June 12, 2018 the FDA approved pembrolizumab (KeytrudaⓇ, Merck & Co. Inc.) for patients with chemotherapy-refractory recurrent or metastatic (r/m) cervical cancer and with a combined positive score (CPS)≥1 PD-L1 level expression.
FDA granted regular approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
FDA approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH), a biosimilar of Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection due to febrile neutropenia in patients receiving myelosuppressive chemotherapy with clinically significant incidence of febrile neutropenia and with non-myeloid cancers
On May 21, the FDA approved avatrombopag (DopteletⓇ, AkaRx Inc.) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo a procedure.
On May 14, 2018 the FDA announced approval of biosimilar epoetin alfa-epbx (Retacrit®, Hospira, a subsidiary of Pfizer) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Epoetin alfa-epbx is also […]
FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation. More Information. May 4, 2018.
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 […]
The FDA granted regular approval to dabrafenib (Tafinlar®, Novartis) and trametinib (Mekinist®, Novartis) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
The FDA granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
On April 10, the FDA approved everolimus tablets for oral suspension (Afinitor Disperz®, Novartis) for the adjunctive treatment of adult and pediatric patients ≥2 years with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
FDA approved rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. More Information.
A growing appreciation of the role of the tumor microenvironment in fostering the development of malignancies is prompting the pursuit of anticancer therapies that target components of this supportive niche as opposed to the tumor itself. Read full article (External website)
Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018. Read full article (External website)
The FDA has granted a priority review to moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia who have received at least 2 prior lines of therapy. Read full article (External website)
Comparison of organoid drug responses with how the patients with metastatic gastrointestinal cancers responded in the clinic Read full article (External website)
A marketing authorization application for olaparib (Lynparza) for the treatment of women with BRCA-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting has been accepted by the European Medicines Agency. Read full article (External website)
Larotrectinib induced an “unprecedented” objective response rate of 93% in patients with TRK fusion–positive solid tumors. Read full article (External website)
Change in indications considers prevention of skeletal related events in adults with advanced malignancies involving bone Read full article (External website)
In an interview with Targeted Oncology, Kris, a medical oncologist and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center, discussed how the approval of durvalumab has changed the treatment landscape of NSCLC. Read full article (External website)
The European Medicines Agency has accepted a marketing authorization application for olaparib to treat women with BRCA-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Read full article (External website)
Investigators report for the first time clinical and genetic risk factors for metabolic syndrome in North American survivors of testicular cancer Read full article (External website)
Based on data from the Phase 3 482 trial, denosumab (Xgeva) has been approved for an expanded indication by the European Commission for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. Read full article (External website)
The European Commission has approved denosumab for the prevention of skeletal-related events in adult patients with multiple myeloma. Read full article (External website)
In an extended follow-up of results from the CheckMate-205 trial, nivolumab (Opdivo) induced an overall objective response rate of 69% in patients with relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic cell transplantation. Read full article (External website)
Older patients with active, relapsed, or refractory acute myeloid leukemia have a low survival rate, very poor risk assessments, and limited therapeutic options, with conventional care consisting primarily of salvage chemotherapy. Read full article (External website)
The impact of staggering increases in the cost of individual antineoplastic agents for patients and the overall healthcare system cannot be overstated, and there appears to be no realistic solution to the current dilemma that is acceptable to the parties involved in this ongoing debate. Read full article (External website)
Thomas J. Lynch, Jr, MD, brings an enthusiasm to exploring and developing treatments to help patients with cancer. Read full article (External website)
Molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia. Read full article (External website)
A novel inhibitor that targets the AKT node in the PI3K pathway may offer a treatment option in cases of resistance to chemotherapy in 2 patient populations: triple-negative breast cancer or estrogen receptor Read full article (External website)
Ani S. Balmanoukian, MD, discusses immunotherapy developments in GU malignancies Read full article (External website)
Stuart L. Goldberg, MD, discussed the management of patients with acute myeloid leukemia as well as those with myelodysplastic syndrome. Read full article (External website)
Noa Biran, MD, discusses treatment breakthroughs and emerging advances in the field of multiple myeloma. Read full article (External website)
Edouard J. Trabulsi, MD, discusses emerging multimodal treatment approaches for patients with locally advanced prostate cancer. Read full article (External website)
Stuart L. Goldberg, MD, discusses the management of patients with acute myeloid leukemia as well as those with myelodysplastic syndrome. Read full article (External website)
The Association of Community Cancer Centers (ACCC) has named Thomas A. Gallo, MS, MDA, as the 2018-2019 president of ACCC. This was announced at the ACCC’s 44th Annual Meeting & Cancer Center Business Summit on March 16, 2018. Read full article (External website)
Denise. L. Pereira, MD, recently shared the treatment considerations and decisions she makes when treating patients with multiple myeloma based on 2 case scenarios during a Targeted Oncology live case-based peer perspectives presentation. Read full article (External website)
According to findings from the Phase 3 MURANO trial recently published in the New England Journal of Medicine, the venetoclax (Venclexta) plus rituximab (Rituxan) regimen lowered the risk of disease progression or death by 83% in comparison with bendamustine (Treanda) plus rituximab (Rituxan) in patients with relapsed or refractory chronic lymphocytic leukemia. Read full article […]
Internationally renowned expert, Johanna C. Bendell, MD, has been promoted to chief development officer at Sarah Cannon. Her title responsibilities include developing and expanding physician, site, and Pharma relationships across the Sarah Cannon Network, thereby expanding the organization’s efforts to bring more qualitative treatment options to its patients. Read full article (External website)
Treatment of renal cell carcinoma (RCC) is awaiting the potential integration of combinations of immuno-oncology agents like nivolumab (Opdivo) and ipilimumab (Yervoy), or combinations of targeted therapies with checkpoint inhibitors into the treatment paradigm. In an interview with Targeted Oncology, Robert A. Figlin, MD, discusses the expanding RCC armamentarium and balancing the benefits and risks […]
Findings from a small, retrospective trial delivered that external beam radiation therapy induced an overall response rate of 86% in patients with relapsed/refractory follicular lymphoma. Read full article (External website)
Kornelia Polyak, MD, PhD, discusses several exciting advancements in the field of breast cancer, including immunotherapy, PARP inhibitors, and liquid biopsies. Read full article (External website)
Bert H. O’Neil, MD, the role of molecular testing throughout GI cancers and highlighted the current and developing treatment landscape for patients with colorectal cancer. Read full article (External website)
The emergence of immune checkpoint inhibitors as an effective treatment strategy is a result of increased understanding of the elaborate relationship between tumor cells, their microenvironment and the host immune response. Read full article (External website)
Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease. Read full article (External website)
Tanios Bekaii-Saab, MD, discusses emerging treatments offering hope to patients with pancreatic cancer. Read full article (External website)
In an interview with Targeted Oncology, Pollack, assistant member, Clinical Research Division, assistant professor, Division of Oncology, University of Washington, and attending physician at Seattle Cancer Care Alliance, discussed some of the advancements his lab is making in the field of sarcoma. Read full article (External website)
Adding trastuzumab to chemotherapy increased progression-free survival for patients with advanced HER2/neu-positive uterine serous carcinoma, Read full article (External website)
Based on data from 2 clinical trials, nilotinib (Tasigna) has been approved by the FDA for the first- and 2nd-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. Read full article (External website)
Manish A. Shah, MD, discusses the advancements being made in the treatment of patients with advanced gastric and gastroesophageal junction cancer. Read full article (External website)
It is indicated for prevention of nausea and vomiting associated with highly and moderately emetogenic chemotherapy in adult and paediatric patients Read full article (External website)
The new drug application (NDA) for larotrectinib (LOXO-101) for treatment of patients with locally advanced or metastatic solid tumors that habor an NTRK gene fusion has been completed. Read full article (External website)
It is indicated in adult and paediatric patients in first or second complete remission with minimal residual disease Read full article (External website)
There has been a supplemental biologics license application (sBLA) granted priority review by the FDA for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases of metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan. Read full article […]
Bruce D. Cheson, MD, recently shared the treatment options and decisions he makes when treating patients with follicular lymphoma based on 2 case scenarios during a Targeted Oncology live case-based peer perspective presentation. Read full article (External website)
Robert B. Den, MD, discusses bone-targeting agents in prostate cancer and the potential future of combinations. Read full article (External website)
Management of depression remains important for its beneficial effect on QoL in cancer patients Read full article (External website)
The combinations of atezolizumab and cobimetinib induced a 31% disease control rate in patients with heavily-pretreated metastatic colorectal cancer. Results from a 2-stage phase Ib trial presented at the 2018 Gastrointestinal Cancers Symposium demonstrated an overall response rate of 8% (n = 7). All responses were partial responses. Read full article (External website)
Jason M. Long, MD, discusses the latest developments with minimally invasive surgical approaches in the treatment of patients with non–small cell lung cancer (NSCLC). Read full article (External website)
This survey is organised by the ESMO/SIOPE Cancer in Adolescent and Young Adults (AYA) Working Group following successful mapping of the European AYA cancer care landscape. Read full article (External website)
Based on data from the Phase 3 PROSPER trial, a supplemental new drug application for enzalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer has been granted a priority review by the FDA, according to Pfizer and Astellas, the companies developing the antiandrogen agent. Read full article (External website)
William K. Kelly, DO, discusses the evolving imaging techniques and emerging therapeutic approaches in prostate cancer. Read full article (External website)
The project aims to improve understanding of prostate cancer genomics through direct-to-patient approach Read full article (External website)
In a national coverage determination issued March 16, CMS announced that it will cover diagnostic laboratory tests using next-generation sequencing for patients with advanced cancer. Read full article (External website)