Showing posts from September, 2019

EMA committee recommends approval of Bristol-Myers Squibb's new Opdivo dosing regimen

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W) or 480 mg infused over 60 minutes every four weeks (Q4W) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). “This positive CHMP opinion for Opdivo two and four-week dosing reinforces our commitment to offering flexible dosing options for patients, caregivers and healthcare providers,” said Ralu Vlad, Pharm.D, development team lead, product design and delivery, Bristol-Myers Squibb. “We look forward to the European Commission’s decision and potentially bringing this new Opdivo

Eisai Pharmaceuticals inks pact with Mylan India to promote and distribute second brand Teceris

Eisai Co, announced that Eisai’s subsidiary Eisai Pharmaceuticals India Pvt Ltd and Mylan India have entered into a license agreement to promote and distribute the second brand Teceris for the anticancer agent eribulin mesylate (eribulin) in India. Under this agreement, eribulin will be supplied to Mylan India by Eisai India as well as promoted and distributed by Mylan India as Teceris. Mylan India has a wide portfolio of medicines in oncology and brand building ability in India. Eisai group positions this agreement as an important strategy for expanding access to eribulin following the tiered-pricing model in which the cost burden to patients is differentiated according to income level. Further availability of eribulin to patients all over India is expected by supplying eribulin in two brands, two channels: Halaven by Eisai India and Teceris by Mylan India. Eribulin is a novel anticancer agent discovered in-house by Eisai. In India, Eisai is steadily expanding the availability of eri

India launches global cancer care network, 11 nations want to join

India has launched one that will allow the integration of hospitals and cancer care institutes from partner countries with the National Cancer Grid (NCG) in the country. The goal of the network is to eliminate the disparity in cancer care worldwide. KN Vyas, secretary of the Department of Atomic Energy (DAE) and president of the Atomic Energy Commission, after launching the global cancer care network in Vienna on Tuesday on the sidelines of the 63rd IAEA General Conference, said: I am happy to announce that India is launching NCG-Vishwam Cancer Care Connect (NCG-Vishwam 3C). Vishwam is a Sanskrit word that means universal or global. Through this connection, we will join hands with all partner countries interested in our fight against cancer. Vyas said: Our partner countries will benefit in different ways through NCG Vishwam connect, such as NCG guidelines for the management of common cancers, second opinion service for patients and doctors, treatment decisions and course availability.

Seattle Genetics, Astellas gets USFDA priority review for Enfortumab Vedotin

US FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer Seattle Genetics, Inc. and Astellas Pharma Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. The filing is based on results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial that were presented as a late-breaking oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2019. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020. Enfortumab ve

US FDA grants breakthrough therapy status to Merck's tepotinib in patients with metastatic NSCLC with METex14 skipping alterations

Merck KGaA, a leading science and technology company, which operates its biopharmaceutical business as EMD Serono in the US and Canada, announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the investigational targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy. "Tepotinib was associated with robust objective responses with durability that has not previously been seen in patients with metastatic NSCLC harboring MET exon 14 skipping alterations, selected by either tissue or liquid biopsy approaches," said Luciano Rossetti, global head of research & development for the Biopharma business of Merck KGaA, Darmstadt, Germany. "This breakthrough therapy designation further underscores the potential of tepotinib, and we aim to advance this program and deliver this medicine as quickly as po

FDA Approval of Roche Cancer Drug Confirms Beginning of New Oncology Era

With nothing more than a passing glance, the U.S. Food & Drug Administration's (FDA) approval of Roche Holdings' ( OTC:RHHBY ) cancer drug entrectinib last month was a run-of-the-mill announcement. In fact, it was almost boilerplate in its tone and feel. Greenlighting the drug, however, means that Roche has secured more than just another profit center. Entrectinib also helps to usher in an entirely new era of oncology. It's only the third FDA-approved treatment to combat certain types of tumors, regardless of where they're found in the body. Until now, pharmaceutical companies effectively were required to pinpoint where a tumor was being targeted in order to secure regulatory approval. In other words, with the third such therapy now in the books, Roche may have made the idea of "tissue agnostic" tumor treatments a new norm. Rozlytrek is a big fish in a little pond Technically speaking, it was Roche subsidiary Genentech that was able to win the FDA's a

AstraZeneca's Imfinzi prolongs survival in aggressive lung cancer

AstraZeneca 's cancer treatment Imfinzi has been shown to prolong survival in a particularly aggressive type of lung cancer by close to three months, as the British drugmaker holds its ground in a crowded field against rival immunotherapy drugs. Imfinzi, when combined with chemotherapy , resulted in a median 13 months survival in a late-stage small cell lung cancer trial, the British drugmaker said on Monday, adding trial details to a brief statement published in June. Patients in a reference group on chemotherapy only lived a median 10.3 months in the so-called Caspian trial, it said. "There is a wide recognition that in small cell lung cancer there is very much a need for new therapies," said Dave Frederickson, head of the company's oncology business. "There is a clear imperative that chemotherapy alone is not delivering the outcomes that we desire for patients because the disease is so aggressive." AstraZeneca has already carved out a niche for Imfinz

Amgen drug shrinks lung cancer tumors in half of patients

An experimental Amgen Inc drug that targets a specific genetic mutation reduced tumor size in around half of advanced lung cancer patients given the highest dose in a small, early-stage trial, the company said on Sunday. Out of 13 lung cancer patients taking a 960-milligram dose of AMG510, seven had tumors shrink by at least 30%, according to data presented in Barcelona at the World Conference on Lung Cancer. Cancer was stabilized in the other six high-dose patients. Nine of the 13, or 69%, are still taking the daily pill. Two of the partial responders have died, and another left the study due to cancer progression. One patient with stable disease also died. Patients who responded to the drug have been treated for a median of 15 weeks, but the median duration of response has not been reached, according to Greg Friberg, head of oncology development at Amgen. He said one patient previously reported as free of lung cancer is being counted as a partial responder since cancer in lymph node

Lupin signs second partnership for its oncology pipeline, this time with German drug maker BI

BI and Lupin will together develop and commercialise a new drug called MEK inhibitor that will target specific cancer cells and potentially treat patients of skin and stomach cancer. Indian pharma major Lupin and German drug maker Boehringer Ingelheim (BI) will come together to work on a cure for cancers which has never been treated before. BI and Lupin will together develop and commercialise a new drug called MEK inhibitor that will target specific cancer cells and potentially treat patients of skin and stomach cancer. Lupin will receive an upfront payment of $20 million with potential additional payments upto $700 million upon successful achievement of defined clinical, reclinical, regulatory and commercial milestones. The company is also expected to receive double-digit royalties on the sales of the product upon commercialisation which would take at least seven years. The partnership will compliment BI’s ongoing innovation on the new pathway called the KRAS inhibitors, which severa