Showing posts from February, 2018

Cipla ties up with Roche to sell 2 cancer drugs in India

Drug firm  Cipla  today said it has entered into an agreement with  Roche   Pharma  to promote and distribute the latter's cancer drugs in India. The pharma major will distribute  Tocilizumab  and Syndyma -- the second brand of Roche's cancer therapy bevacizumab -- in India. This partnership is in line with Cipla and Roche's efforts to improve healthcare and increase access to innovative, life-changing medicines in India, particularly to patients who currently do not have access to them, Cipla said in a filing to BSE. Commenting on the development, Cipla MD & Global CEO  Umang Vohra  said: "The prevalence of cancer and rheumatoid arthritis is widely spread across India, and Cipla can contribute to provide broader access to innovative medicines like tocilizumab and bevacizumab." "At Roche, improving access to the critical medicines that patients need is an integral part of what we do,"  Roche Pharma  India MD  Lara Bezerra  said. This part

Lilly breast cancer drug wins expanded U.S. approval

U.S. regulators have approved expanded use of  Eli Lilly  and Co's Verzenio  breast cancer drug  as an initial treatment for certain women with advanced or metastatic disease, a decision that should boost sales of the medicine, the company said on Monday. The Food and Drug Administration approved the drug in combination with an aromatase inhibitor in previously untreated postmenopausal women with HR positive, HER2-negative advanced  breast cancer . Verzenio was originally approved last September in combination with AstraZeneca's Faslodex (fulvestrant) once the disease had progressed following endocrine therapy. The Lilly oral drug competes with Pfizer's  Ibrance  and Kisqali from Novartis. The expanded approval was based on a late-stage study in which Verzenio, known chemically as abemaciclib, taken twice a day with either anastrozole or letrozole significantly delayed disease progression compared with a placebo and one of the aromatase inhibitors. "Today&#

100 doctors set up Immuno-Oncological Society to frame treatment norms

An innovation by IIT-Bombay may help reduce the cost of a type of immunotherapy used to treat blood cancer to a tenth of that in the US. “We filed for a patent last month for the manufacture of the CAR-T cell therapy and hope it would eventually be available at a tenth of the US cost,” said Dr  Rahul Purwar  from IITB’s biosciences department. It would take another couple of years before the medicines are available for clinical trial at Tata Memorial Hospital, Parel. CAR-T cell therapy is one of the many immunotherapy agents that promise to treat cancer by tweaking a patient’s own immune system. While immunotherapy agents were used as the “last resort” for patients with advanced cancer till a few years back, it is emerging as the chosen treatment for certain cancers such as melanoma or that of the skin. At a scientific meeting held at Tata Memorial on Saturday, around 100 doctors from across the country who are interested in immunotherapy, set up Immuno-Oncological Society of India. “

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients with stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approve

FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint

The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. “The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agenc

NICE recommends funding for three thyroid cancer drugs

NICE has recommended in draft guidance that three thyroid cancer treatments can receive regular NHS funding, finally approving a drug from Eisai after a delay of more than two years because it fell through several gaps in the body’s review process. All the drugs got through NICE after the manufacturers offered commercially confidential discounts. Eisai’s Lenvima (lenvatinib) was refused entry into the Cancer Drugs Fund (CDF) in 2016, because the scheme to provide interim funding for  oncology  drugs that cannot be funded regularly on the NHS was closed to new entries at the time. Lenvima was also not scheduled for assessment by NICE because of its low budget impact, and as a result NICE delayed its review of the drug’s cost-effectiveness. Gary Hendler, chairman & CEO EMEA, and chief commercial officer, Oncology Business Group at Eisai, said: “After almost three years of being licensed in the EU, I am really very pleased that NICE is finally recommending the use of lenvati

Delhi: AIIMS may open cancer centre at ITO

Looking at the rising incidence of cancer in the country, the All India Institute of Medical Science (AIIMS) is likely to establish a cancer care centre at the ITO in the national Capital. The Yuva Bharati Trust has signed a memorandum with AIIMS, Indian Society of Oncology and National Cancer Institute (NCI) to establish a cancer centre. For this, the Yuva Bharti Trust has planned to provide a space to AIIMS at Chandra Shekhar Bhawan area in ITO. The project was in the pipeline for a long time. The Yuva Bharati Trust has approached us with an idea to start with cancer screening centre like AIIMS. This centre will provide cancer screening facilities, vaccination for cervical cancer, tele-oncology and diagnostic facilities, AIIMS Dr Abhishek Shankar, senior oncologist, said adding that the name of the centre has been proposed as Chandra Shekhar Centre for Cancer Care. The new cancer centre will alert people about the cancer screening at an early stage so that

Biosimilar Herzuma approved in EU

The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The positive decision for South Korean firm Celltrion (Kosdaq: 068270) follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017. It follows the EC approval of Samsung Bioepis’ trastuzumab biosimilar, Ontruzant, in November last year. Other biosimilars of Roche’s blockbuster breast and gastric cancer drug Herceptin include the partnership of India’s Biocon (BSE: 532523) and Netherlands-headquartered Mylan (Nasdaq: MYL), with the latter duo one of the leaders in the race for  approval in the USA , where the last composition of matter patent for the original will expire in 2019.Herceptin sales in full-year 2017 grew 3% to 7.01 billion Swiss francs ($7.5 billion). “The devel