Showing posts from December, 2019

AstraZeneca, Merck's Lynparza gets US FDA approval to treat pancreatic cancer

AstraZeneca and MSD Inc, announced that Lynparza (olaparib) has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza. The approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee (ODAC) on 17 December for Lynparza in this indication, and was based on results from the pivotal phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting. Results showed a statistically significant and clinically meaningful improvement in progression-free survival, where Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic

Astellas Strengthens Immuno-oncology Pipeline with Acquisition of Xyphos Biosciences, Inc.

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Xyphos Biosciences, Inc. (CEO: James Knighton, "Xyphos") today announced that Astellas has acquired Xyphos. With the acquisition Astellas will gain Xyphos' novel and proprietary ACCEL (Advanced Cellular Control through Engineered Ligands) technology platform, as well as industry-leading immuno-oncology talent, to develop new and potentially better ways to mobilize, target and control immune cells to find, modulate and destroy targeted cells throughout the body. "At Astellas, immuno-oncology is a Primary Focus of our research and development strategy, and we are working on the development of next-generation cancer immuno-therapy using new modalities/technologies," said Kenji Yasukawa, President and CEO, Astellas. "The innovative technology in development at Xyphos fits perfectly in advancing our immuno-oncology strategy to create and deliver value for patie

EC approves Roche’s Kadcyla to treat HER2-positive early breast cancer

Roche has announced that the European Commission has approved Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. “Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This approval of Kadcyla will allow many more women with HER2-positive early breast cancer to be given a transformative treatment that may cut the risk of their disease returning or progressing." The goal of neoadjuvant treatment is to shrink tumours in order to help improve surgical outcomes. Adjuvant treatment aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.1 People who

US FDA grants priority review status to Pfizer's sNDA for Braftovi in combo with Erbitux to treat BRAFV600E-mutant metastatic colorectal cancer after prior therapy

Pfizer announced that the US Food and Drug Administration (FDA) has accepted and granted priority review to the company’s supplemental New Drug Application (sNDA) for Braftovi (encorafenib) in combination with Erbitux (cetuximab) (Braftovi Doublet) based on results from the phase 3 BEACON CRC trial, which evaluated the efficacy and safety of Braftovi in combination with Erbituxwith or without Mektovi (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. As published in The New England Journal of Medicine (NEJM), results from the BEACON CRC trial showed improvements in overall survival (OS) and objective response rates (ORR) for both the Braftovi Doublet and Braftovi Triplet (Braftovi, Mektovi and Erbitux) combination, compared to Erbituxplus irinotecan-containing regimens (Control). In descriptive analyses comparing the Doublet and Triplet arms, the results showed comparable efficacy between the Doublet and

Natco launches cut price versions of cancer drug ibrutinib in india

Hyderabad-based Natco PharmaNSE -0.01 % has launched a cut price version of ibrutinib, an anti-cancer drug, under its own brand name Ibrunat. The patent for the drug is held by Pharmacyclics for three to four more years in India. Pharmacyclics was globally acquired by US giant AbbVie in 2015 in a massive USD21 billion deal. In India, the marketing right for ibrutinib is held by Johnson & Johnson. Ibrutinib is used to treat patients with leukemia and similar other indications of cancer. A Natco official confirmed its launch but refused to divulge more details. It is learnt that the Indian drug maker has already dispatched the drug in distribution channels. The Natco drug will cost at approximately INR 38000 per month as opposed to INR 4 lakh course of the innovator. A patient is expected to take 4 tablets each day. Sources informed ET that Pharmacyclics had filed for an injunction petition in Delhi High Court but no clear decision was handed out. Natco was directed to maintain data

FDA grants accelerated approval for Astellas, Seattle Genetics' bladder cancer drug

U.S. Food and Drug Administration said on Wednesday it approved Astellas Pharma Inc and Seattle Genetics ' experimental drug to treat advanced bladder cancer, about three months ahead of schedule. Shares of Seattle Genetics were up 6% at $119.05 after the bell. The drug, Padcev , is the first FDA approved treatment in the United States for patients with advanced or metastatic urothelial cancer , the companies said. The drug will treat patients with advanced bladder cancer whose disease has progressed even after treatment with immunotherapy and chemotherapy. The American Cancer Society estimates 17,670 people will die from bladder cancer in the United States this year. The continued approval of the drug may depend upon verification of clinical benefit in confirmatory trials, the companies said, adding that a late-stage study is underway. The FDA's accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition. So

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 to recommend Lynparza (olaparib) as a 1st-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed following 1st-line platinum-based chemotherapy. In August 2019, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza for this indication with Priority Review and set a Prescription Drug User Fee Act (PDUFA) date for the fourth quarter of 2019. José Baselga, Executive Vice President, Oncology R&D, said: “We are pleased with the ODAC’s recommendation for Lynparza and the potential to bring a personalised, biomarker-targeted medicine to patients with germline BRCA-mutated metastatic pancreatic cancer. Patients with advanced panc

WHO moves step closer to cheaper breast cancer treatment

The World Health Organization (WHO) announced Wednesday that it had for the first time approved a "biosimilar" medicine -- one derived from living sources rather than chemicals -- to make breast cancer treatment affordable to women globally. The trastuzumab drug has shown "high efficacy" in curing early stage breast cancer and in some cases more advanced forms of the disease, the WHO said in a statement. But the annual cost of the original drug is an average (of) USD 20,000, "a price that puts it out of reach of many women and healthcare systems in most countries," the statement added. However, the biosimilar version of trastuzumab is generally 65 per cent cheaper than the original. "With this WHO listing, and more products expected in the prequalification pipeline, prices should decrease even further," the WHO said. The cheaper but equally effective biotherapeutic medicines are produced from biological sources such as cells rather than synth

US FDA approves Xtandi to treat mCSPC

Pfizer and Astellas Pharma announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). In 2019, it is estimated that just over 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone. With this approval, Xtandi is now the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC. The approval is based on results from ARCHES, a randomised phase 3 study which evaluated 1,150 men with mCSPC and met its primary endpoint of radiographic progression-free survival (rPFS). “Men with metastatic castration-sensitive prostate cancer face complex treatment

Centre approves setting up of 18 state cancer institutes and 20 tertiary care cancer centres across the country

To enhance the facilities for tertiary care of cancer, the Central government has approved setting up of 18 state cancer institutes and 20 tertiary care cancer centres across the country as part of its strengthening tertiary care for cancer scheme. The Tata Memorial Centre (TMC) through the Department of Atomic Energy (DAE) is also planning to set up six other cancer centres in different parts of the country on par with TMC, Mumbai. These will be located in Varanasi (two centres), Guwahati, Sangrur, Vishakapatnam and Mullanpur and will cater to a large number of patients with cancer in all four zones of the country. The two campuses in Mumbai (Parel and Navi Mumbai) are also undergoing expansion in capacity. TMC has established the National Cancer Grid, which is a network of 193 cancer centres, research institutions, patient groups, professional societies in the country with the mandate of creating uniform standards of cancer care in India. Further, oncology is also one of the focus a

HIVEC is next big step to prevent recurrence in superficial bladder cancer

Cancerous tumours in the genito-urinary system are amongst the most common type of cancers occurring in patients diagnosed with the life-threatening disease. According to studies in recent years, genito-urinary cancers are common amongst Indian males and females, accounting for nearly 21 per cent of all cases. In males, 30.4 per cent of genitourinary system malignancies (17.50 per cent) consisted of urinary bladder malignancies. At a global scale, of 356,000 new cases of urinary bladder cancer diagnosed annually, the disease results in the death of 145,000 patients. Currently, bladder cancer in India is treated with Bacillus Calmette-Guerin (BCG) intravesical immunotherapy. It is a prevalent procedure in India as it is cost-effective. And, it is a painful procedure. However, studies have shown a high-recurrence of the disease in non-muscle invasive bladder cancer (NMIBC) patients post BCG treatment. When procedures like BCG and others fail, a cystectomy (removal of the bladder) has to

Sanofi to acquire immuno-oncology company Synthorx for $2.5B

A French drugmaker is putting down $2.5 billion to acquire a U.S. biotech developing immunotherapies in oncology and rheumatology. Paris-based Sanofi said Monday it would acquire San Diego-based Synthorx . Shares of the biotech company were up 169% on the Nasdaq when markets opened following the news. Synthorx’s lead drug candidate is THOR-707, an IL-2 therapeutic that it has in development both as a single agent and in combination with immune checkpoint inhibitors, with a Phase I/II clinical trial ongoing. The company has recently presented preclinical data that it said bolsters the case for the drug. Marketed checkpoint inhibitors include Merck & Co.’s Keytruda (pembrolizumab) and AstraZeneca’s Imfinzi (durvalumab), among others. IL-2, which stands for interleukin-2, is a protein made by white blood cells that promotes the growth and activity of other white blood cells. Sanofi touted THOR-707 as having potential to demonstrate improved pharmacology, less frequent dosing and th

Merck to buy biopharma company ArQule for US$ 2.7 billion

Merck and ArQule, announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion. ArQule, is a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. ArQule’s lead investigational candidate, ARQ 531, is a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a phase 2 dose expansion study for the treatment of B-cell malignancies. “ArQule’s focus on precision medicine has yielded multiple clinical-stage oral kinase inhibitors that have novel and important properties,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This acquisition strengthens Merck’s pipeline with the addition of these strategic assets including, most notably, ARQ 531, a compelling candidate for the treatment of B-cell malignancies.” BT

Mumbai set to get hi-tech proton machine for safer cancer therapy

One of the world’s most sophisticated forms of cancer treatment is coming to Mumbai. The proton beam therapy machine, which provides sub-millimetre precision in destroying cancer cells, is expected to be installed at Kharghar’s Tata Memorial Centre by September 2020. The machine, of which there are barely 120 worldwide and one in India, will be made available to at least half the patients at one-tenth of what it costs in the US; a single cycle of treatment will still run up a bill of Rs 10-12 lakh though. However, those who cannot afford it will get free treatment. “…by September 2020, we should be ready,’’ said Dr Siddhartha Laskar, the radiation oncologist from Tata Memorial Hospital, Parel, overseeing the project. Roughly, 50-60% of all cancer patients need radiation. Doctors say the proton beam is safer than standard radiation therapy performed using X-rays which have a tendency to pass through a body. Kharghar centre to offer patients subsidised therapy After Apollo Cancer Centre

US FDA approves Roche's Tecentriq plus chemotherapy to treat metastatic non-squamous NSCLC

Roche announced that the US Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations. “We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and Head of Global Product Development. “Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease.” This approval is based on results from the phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival

Piramal Pharma Solutions partners with Norway-based BerGenBio to develop blood cancer drug

Piramal Pharma Solutions, the contract development and manufacturing arm of Piramal Enterprises , said on December 3 that it will be partnering with Norway-based BerGenBio for the development of blood cancer drug bemcentinib. Bemcentinib is used for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML). The drug is a first-in-class AXL protein inhibitor (blocks AXL protein) for oncology was recently designated as a fast track status by USFDA, as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need. The bemcentinib development program encompasses a fully integrated program of Piramal's resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, Piramal is also expected to provide commercial manufacturing of the final drug product. The financial d