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Showing posts from October, 2017

New drug may prevent chemotherapy-induced nerve damage

  Researchers  have successfully tested a new molecule that is capable of preventing the development of a nerve damaging condition caused by  chemotherapy treatment in  cancer  patients. Chemotherapy-induced peripheral neuropathy is the most prevalent neurological complication of anti-cancer treatment and a common dose-limiting side effect. An estimated 30 per cent to 40 per cent of cancer patients who receive chemotherapy experience the neurological complication, characterised by tingling, numbness, weakness and pain from nerve damage, usually in the hands and feet. This causes a negative impact on the quality of life of the patient, and leads to dose reduction or discontinuation of chemotherapy, with the potential decrease of survival chances that entails. However, the new molecule was found to prevent the onset of this adverse effect, said researchers from the Bellvitge University Hospital in Spain. The findings, of the clinical trial detailed in the journal...

Gilead cancer immunotherapy wins U.S. approval with $373,000 price

A new therapy for a type of lymphoma developed by Kite  Pharma , which was acquired by  Gilead  Sciences Inc, won U.S. approval on Wednesday, marking the second approval for this potentially revolutionary approach to fighting  cancer . Gilead said the price for the therapy with one-time administration would be $373,000. Gilead Sciences shares rose almost 4 percent to $83 in extended trading. The therapy, to be sold under the brand name Yescarta, is the second in a new class of cancer treatments known as chimeric antigen receptor T-cell therapy, or CAR-T, which reprograms the body's own immune cells to recognize and attack malignant cells. The first drug in the class,  Novartis  AG's Kymriah, costs about $475,000 for the one-time treatment. It was approved in August for B-cell acute lymphoblastic leukemia, the most common form of childhood cancer in the United States. Yescarta is approved to treat adults with relapsed or refractory large B-cell l...

FDA approves Lilly pill for common advanced breast cancer

Eli Lilly's Verzenio was approved Thursday by the Food and Drug Administration for women and men with what's called HR-positive, HER2-negative breast cancer that has worsened after hormone therapy. According to the FDA, about 72 percent of patients with breast cancer have this type. The daily pill blocks certain enzymes that promote growth of cancer cells. It's to be used either alone, after hormone therapy and chemotherapy have stopped working, or in combination with a hormone therapy called fulvestrant. Play Current Time 0:00 / Duration Time 0:00 Loaded : 0% Progress : 0% 0:00 Fullscreen 00:00 Mute Indianapolis-based Eli Lilly and Co. says Verzenio, which is taken until cancer resumes growing, will cost $10,948 per month. It's offering patients financial assistance, including 12 months with a minimal copayment for those with commercial insurance. It will compete with two drugs in the same ...

Eli Lilly to collaborate with Germany's CureVac on cancer vaccines

U.S. drugmaker  Eli Lilly and Co  said on Wednesday it will collaborate with CureVac AG on development of up to five immunotherapy cancer vaccines using the German company's messenger RNA (mRNA) technology. Under terms of the deal, CureVac will receive $50 million up front and Lilly will take an equity stake in CureVac worth about $53 million (45 million euros). Once the deal clears regulatory scrutiny, Lilly said it will take a charge to earnings of about 3 cents per share. The collaboration calls for Lilly to be responsible for identifying cancer targets, clinical development and commercialization, while CureVac will handle mRNA design, formulation and manufacture of vaccine for clinical supply, the companies said. CureVac retains an option to co-promote any approved vaccine products in  Germany . It will also be eligible to receive more than $1.7 billion in development and commercialization milestones should all five vaccines prove successful, and royalty pay...

AstraZeneca and Chi-Med's Savolitinib Shows Encouraging Clinical Activity in 2nd-Line EGFR Mutation-positive Lung Cancer with MET-amplification

AstraZeneca and its partner Chi-Med today presented preliminary safety and clinical activity of savolitinib when given in combination with either  Tagrisso  (osimertinib) or  Iressa  (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment with an EGFR inhibitor. 1,2  In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of c-MET (mesenchymal epithelial transition factor) receptor tyrosine kinase, to osimertinib (80mg, once daily) or gefitinib (250mg, once daily) demonstrated preliminary anti-tumour activity. The data were shared in two oral presentations at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, 15-18 October 2017. Dr. Myung-Ju Ahn, Department of Haematology ...

Oncologists rely on molecular diagnostics, systemic therapy & invasive in axillary dissection to treat breast cancer

Indian oncologists are now increasingly eyeing novel therapeutic approaches like use of systemic therapy along with invasive in axillary dissection and molecular diagnostics to stall the morbidity of breast cancer (BC).  This is because of aggressive cancers manifesting in the young age group.   Currently, incidence of BC among young women is around 1.7 million new cases diagnosed yearly with an annually fatality reported at 5,20,000.    Newer drugs for BC are Pertuzumab from Genentech, Palbociclib: Pfizer, Everolimus: Novartis, Abraxane: Abraxis Bioscience, Ado-Trastuzumab Emtansine from Genentech, Ribociclib from Novartis & Astex, Neratinib Maleate by Puma Biotechnology and Abemaciclib from Lilly.  There are over 260 ongoing clinical breast cancer trials in India. The challenge is lack of awareness and reporting any changes on time to a doctor . It is here that late detection directly decreases long term survival of the patient, Dr. D G Vijay – Consultant...

Tata Memorial will run railways' cancer hospital in Varanasi

The  Indian Railways Cancer Institute  and  Research  Centre, which caters to thousands of non-railway patients as well every year, will be re-launched in 3 months Tata Memorial Hospital , the country's top cancer treatment facility that provides free care to thousands of patients, has now taken over the Railway Cancer Hospital in Varanasi at the behest of Prime Minister Narendra Modi, who is a Member of Parliament from Varanasi. The 101-bed hospital, officially the Indian Railways Cancer Institute and Research Centre, is located in Varanasi's Lahartara locality. It receives non-railway patients as well, especially from the North-East, but because of lack of infrastructure, most patients are referred to other  hospitals , mainly  Tata Memorial . A few months ago, the Tata Memorial top brass was asked by the Prime Minister's Office whether it can take over the Varanasi hospital from the railways, as there has been several complaints about the lack of infras...

FASLODEX (FULVESTRANT) RECEIVES POSITIVE CHMP OPINION FOR THE TREATMENT OF HORMONE RECEPTOR-POSITIVE ADVANCED BREAST CANCER IN COMBINATION WITH PALBOCICLIB1

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a new indication for  Faslodex  (fulvestrant) that will expand its use to include combination therapy with palbociclib. 1  The combination use is for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. Klaus Edvardsen, Head of Oncology Global Medicines Development at AstraZeneca said: “This positive CHMP opinion builds on the growing body of evidence around the potential of fulvestrantin combination with targeted therapies, such as palbociclib. Fulvestrant  - based treatment regimens may provide new options for patients with advanced breast cancer for whom there is still an unmet medical need. This is why many current clinical trials exploring the...

CHMP recommends EU approval of Roche’s Alecensa (alectinib) as a first-line treatment for people with ALK-positive NSCLC

Roche announced today that the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Alecensa® (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). It has also simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to a full marketing authorisation. The CHMP recommendation in first-line is based on results from the global phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 53% (HR=0.47, 95% CI: 0.34-0.65, p<0.001) compared with crizotinib. The study also showed that Alecensa reduced the risk of tumours spreading to, or growing in, the brain or central nervous system (CNS) by 84% (HR=0.16, 95% CI: 0.10-0.28, p...

Datar Cancer Genetics Launches Breakthrough Blood Test for Early Detection of 15 Cancers

Early detection of cancer has been the Holy Grail for scientists all over the world. Late stage detection is one of the primary reasons for death in cancer patients. Datar Cancer Genetics has developed a simple non-invasive blood test to detect the presence of cancer in seemingly healthy persons, using advanced molecular analysis of nano particles released by cancer cells. The pattern of various genes expressed in the cancer cells is captured in these nano particles known as ‘exosomes’. This breakthrough technology has been developed in India using latest Artificial Intelligence techniques and is based upon the study of more than 3000 samples from cancer patients. The test analyzes all 22000 protein-coding genes in the human genome and is able to detect the presence of breast, cervices, ovary, endometrium, lung, colon, sarcoma and many more cancers with an accuracy of better than 95%.   The test is available in all cities in India and the company has made arrangements for collecti...

Assam govt and Tata Trusts to set up 3-level cancer care grid including South Asian cancer research centre

The information has been shared by Assam health minister Himanta Biswa Sarma who met Ratan Tata, the Chairman of Tata Trusts and other members of the Trusts in Mumbai. The Assam health minister on Thursday tweeted that, in what may become a rare philanthropy-government collaboration on cancer care and management. Government of Assam and Tata Trusts are working on setting up a 3-level cancer care grid at state, capital and district levels. "Unique cancer care grid likely to have investment of Rs 1400 crore and proposed to be shared between Tata Trusts and state, also leverage existing schemes. Level-1 or state level cancer care institution at Guwahati to have advanced, tertiary care facilities and shall cater to needs of entire NorthEast. Under grid system, Level-2 or medical college to hv chemo, radiation & surgical oncology, Level-3 or district hospital to have day care, chemo & radiation," Sarma tweeted. Himanta Biswa Sarma also tweeted that, a South Asia...

Biocon gets complete response letter from USFDA for anti-cancer drug

Biotechnology firm Biocon today said the US health regulator has issued complete response letter (CRL) for proposed biosimilar Pegfilgrastim, indicated for use in the treatment of cancer. The company, however said it does not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan. "The U.S. Food and Drug Administration has issued a complete response letter (CRL) for Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim," Biocon said in a regulatory filing. It further said: "The CRL relates to the pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications. The CRL did not raise any questions on biosimilarity, pharmacokinetic/ pharmacodynamic data, clinical data or immunogenicity". "We do not expect this CRL to impa...

Hyderabad-based Cipher making a difference in cancer care

 A serial healthcare-entrepreneur Sonali Srungaram who created Cipher Healthcare that delivers cancer prevention drives, is optimistic that her efforts will help both patients and carers in the country in managing cancer better. Her company has established an oncology venture ‘Cancer Clinics’ in Hyderabad. Cipher which is into the sixth year of its operations has created its clinic in Jubilee Hills to provide integrated services including rehabilitation. The company is now talking to hospitals to create units that will be housed there. Atleast 1-2 units will be created in the next few months in this model. It will also create two more clinics in the next 2-3 years be it in Delhi/NCR or Chennai/Bengaluru or in Telangana and Andhra Pradesh and the alternatives are being currently evaluated. Cipher wants to be an asset light company. Backed with B Tech Computers in New Zealand and MBA from ISB, she served Accenture in Strategy Practice in the UK before moving to India in Decem...

As Cancer Tears Through Africa, Drug Makers Draw Up a Battle Plan

ontinue reading the main story It reminded him, he said, of his work in 2002 helping design the President’s Emergency Plan for AIDS Relief. Pepfar, as it is known, has been a success: over 14 million Africans are now on H.I.V. drugs, many of them thanks to American aid. In a remarkable initiative modeled on the campaign against AIDS in Africa, two major pharmaceutical companies, working with the American Cancer Society, will steeply discount the prices of cancer medicines in Africa. Under the  new agreement , the companies — Pfizer, based in New York, and Cipla, based in Mumbai — have promised to charge rock-bottom prices for 16 common chemotherapy drugs. The deal, initially offered to a half-dozen countries, is expected to bring lifesaving treatment to tens of thousands who would otherwise die. Pfizer said its prices would be just above its own manufacturing costs. Cipla said it would sell some pills for 50 cents and some infusions for $10, a fraction of what they cost...