Showing posts from September, 2017

Indian scientists testing dendritic therapy against cervix cancer

Researchers at the National Institute of Immunology (NII) have identified a tumour antigen that promises to be a potent weapon in combating cervical cancer New Delhi: Cancer of the uterine cervix, also known as cervical cancer, is the second leading cause of cancer deaths among women in India. Almost one lakh women fall victim to the insidious disease every year in the country. Researchers at the New Delhi-based National Institute of Immunology (NII) are in the process of fine tuning a solution that promises to add a highly potent weapon to the armoury against this type of cancer. They have extracted and identified a tumour antigen which seems to hold a lot of promise. The antigen has been named SPAG9. “The tumor antigen, which is expressed in reproductive tract cancers and a variety of malignancies, has proved successful in phase I trials. This means it has been proved to be safe on human subjects. Phase II clinical trials are presently underway to gauge its efficacy. We hope

US approves its first cancer biosimilar, India has several already

The United States of America is now for the first time getting a taste of a locally approved biosimilar drug for treating cancer. What it can do by way of lowering of drug prices, the various other advantages and challenges that come with it. This follows the announcement by the US drug regulator, the USFDA (US Food and Drug Administration) on Thursday, September 14th that it has approved the first biosimilar for the treatment of cancer. The regulator has approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) - Innovator company Roche - for the treatment of multiple types of cancer. "Mvasi", a note issued by the USFDA says, "is the first biosimilar approved in the U.S. for the treatment of cancer." Then, the USFDA commissioner Scott Gottlieb is quoted as saying: "Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower health

FDA OKs Follicular Lymphoma Treatment

Officials with the FDA have granted accelerated approval to copanlisib (Aliqopa, Bayer) to treat adults with relapsed follicular lymphoma who have received at least 2 prior treatments systemic therapies. The approval of Aliqopa, which is a kinase inhibitor that works by blocking several enzymes that promote cell growth, was based on data from the CHRONOS-1 single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed following at least 2 prior treatments. In the trial, 59% of patients had a complete or partial response for a median 12.2 months. Aliqopa received an accelerated approval, which allows the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Aliqopa’s clinical benefit, and the sponsor is conducting these studies. Common adverse effects of the treatment include hyperglycemia, dia

Govt to set up 49 cancer centres in 3 yrs

With cancer cases on the rise in the country, the government plans to set up 49  cancer centres  in the next three years. The centres will be in addition to 31 already functioning and upgraded since 2014-15, when the government floated the scheme. The health ministry has drawn up a detailed project plan which will be reviewed by the Prime Minister's Office (PMO) at a high-level meeting on Monday. According to the proposal, reviewed by TOI, the ministry has estimated a cost of around Rs 3,495 crore to implement the scheme over the next three years. The cancer centres will be set up in a phased manner under the existing National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke. Non-communicable diseases, especially cancer, are increasing at an alarming rate. However, there is a serious dearth of facilities, mainly at the district level. The idea is to make treatment options available across India so that patients do not necessarily have to

Dr. Reddy’s arm to test Curis’ cancer product in India

Aurigene Discovery Technologies Ltd, a wholly owned subsidiary of Dr. Reddy’s Laboratories engaged in discovery and early clinical development of therapies to treat cancer and inflammatory diseases, plans to initiate a phase 2 trial in India of Curis Inc’s CA-170, an oral small molecule targeting the immune checkpoints PDL1 and VISTA. This follows Aurigene’s collaborator and licensee of CA-170 Curis Inc presenting the preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial at the European Society for Medical Oncology 2017 Congress, a release from Dr. Reddy’s on Tuesday said. The trial was conducted in the US, South Korea and Spain. Curis is a biotechnology firm focused on development and commercialisation of innovative and effective therapeutics for treatment of cancer. Immune checkpoints are the body’s mechanism to prevent the immune system from going into an overdrive while combating infections. “With Curis we have des

MSD launches blockbuster cancer drug Keytruda in India

US biopharmaceutical giant Merck, Sharpe and Dohme (MSD) has launched its blockbuster cancer drug ‘Keytruda’ (pembrolizumab) in India around a year after it first received approvals to market it, said persons aware of the development. The drug has so far only been approved here for a less prevalent type of cancer, while it is marketed in countries like the US to treat additional indications like a specific kind of lung cancer.  Keytruda, hailed as a ‘gamechanger’ therapy in oncology, , is expected to help the immune system identify and selectively combat only cancerous cells instead of aggressively attacking cancer cells and risking healthy tissues in the process like existing therapies. The drug generated global sales of $1.4 billion during 2016.  The Drug Controller General of India (DCGI) gave MSD permission to market Keytruda in June 2016, according to minutes of the regulator’s Subject Expert Committee on oncology and haematology.  A person close to the development said the co

Indian-origin scientist leads A*STAR team growing micro-tumour models for more targeted cancer therapy

In a remarkable breakthrough, Singaporean researchers have successfully grown micro-tumour models outside the human body and used them to identify alternative treatment options for cancer patients who are suffering from resistant or metastatic disease, meaning that they fail to respond to standard-of-care cancer drugs. This innovation will offer hope to the numerous cancer patients grappling with this dreaded disease. The study has been led by Indian-origin Dr Ramanuj Dasgupta, who is the Group Leader, Cancer Therapeutics and Stratified Oncology at the Genome Institute of Singapore (GIS) of Agency for Science, Technology and Research (A*STAR). The study has also been published in  Nature Communications  magazine. Singaporean researchers have successfully grown micro-tumour models outside the human body and used them to identify alternative treatment options for cancer patients. Photo courtesy: This new discovery offers potential to predict treatment response to

Cancer immunotherapy proves itself in earlier-stage disease

* Immuno-oncology moving beyond metastatic cancer * Shift promises to expand market for blockbuster medicines * Astra, Bristol trials show drugs work in earlier disease  Cancer doctors are widening the net for immunotherapy, a hot new class of drugs that enlist the body's defences in the fight against tumours. The latest research shared with 23,000 experts at Europe's top oncology meeting shows how medicines that have already delivered durable benefits in metastatic disease can also work well at an earlier stage. The findings promise to expand the market for established immuno-oncology (I-O) drugs from companies like  Merck , Bristol-Myers Squibb and  Roche , while opening up a window for relative latecomers such as  AstraZeneca . AstraZeneca stole much of the limelight at the  European Society for Medical Oncology  ( ESMO ) congress in Madrid after clinical trial results showed its I-O drug  Imfinzi  helped lung cancer patients with mid-stage disease. Bristol-M

Eli Lilly takes on Pfizer, Novartis with new breast cancer drug data

Eli Lilly staked its claim for a slice of sales in a new class of breast cancer drugs on Sunday as clinical data showed adding its medicine abemaciclib to standard therapy reduced the risk of disease progression by 46 percent. Experts at the European Society for Medical Oncology (ESMO) congress in Madrid said the experimental drug's efficacy was comparable to that of rival drugs from Pfizer and Novartis already on the market. Abemaciclib, like Pfizer's Ibrance and Novartis's Kisqali, belongs to a class of oral medicines called CDK 4/6 inhibitors that block cancer cells' ability to divide and proliferate. Adding abemaciclib to standard endocrine therapy led to significant tumour shrinkage in 59 percent of patients compared with 44 percent in those on endocrine drugs alone in the ongoing study dubbed Monarch-3. For the study's main goal of progression-free survival (PFS), women who only received endocrine therapy of letrozole or anastrazole on average went 1

Concomitant chemoradiation should be standard for locally advanced cervical cancer

Neoadjuvant chemotherapy followed by radical surgery did not improve outcomes compared with cisplatin-based concurrent chemoradiation for women with locally advanced squamous carcinoma of the cervix, according to results of a randomized controlled trial presented at the European Society for Medical Oncology Congress. An estimated 528,000 new cases of cervical cancer are diagnosed worldwide each year, and approximately 266,000 women die of the disease annually. Many patients — particularly those in less developed countries —  present with locally advanced disease , meaning the cancer has invaded the tissue that surrounds the cervix. “Giving radiotherapy and simultaneous chemotherapy using cisplatin has been the standard treatment for close to 20 years based on the results of several large high-quality trials,”  Sudeep Gupta, MD, DM,  professor of medical oncology at Tata Memorial Center in India, said during a press conference. “However, despite treatment, about 25% to 40% of pati

Combination Data for Lenvatinib and Pembrolizumab Demonstrate Notable Response Rates for Patients with Advanced Renal Cell Carcinoma

Updated results of advanced RCC cohort from Study 111 support continued investigation of first-line use of the combination in ongoing Phase III study (CLEAR)  Phase Ib/II results to be presented in an oral proffered paper session on Saturday, 9 September at  9:15 a.m. CEST  at  European Society for Medical Oncology  (ESMO) 2017 Congress Eisai today announced interim results from the advanced renal cell carcinoma (RCC) cohort of Study 111 of Kisplyx ®  (lenvatinib) in combination with the Merck & Co., Inc.,  Kenilworth, N.J. , USA (known as MSD outside of  the United States  and  Canada ) anti-PD-1 therapy, pembrolizumab (KEYTRUDA ® ). The results demonstrate that the combination achieved a confirmed objective response rate (ORR) at week 24 of 63% (95% CI: 44 - 80), and disease control rate (DCR, complete response [CR] + partial response [PR] + stable disease [SD]), a secondary endpoint, was 96% (including 33% SD [n=10]). [1]  No new safety signals were found and toxicities we