Showing posts from February, 2020

US FDA accepts GSK’s sNDA for Zejula for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) accepted the company’s submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The application is supported by data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically-meaningful outcomes of niraparib treatment in the first-line maintenance setting. Results from the PRIMA study were presented at the 2019 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine. The PRIMA study enrolled women who resp

US FDA accepts Roche’s BLA for FDC of Perjeta & Herceptin to treat HER2-positive breast cancer

Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.1 “For more than two decades, our medicines have redefined the standard of care for people with HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of Global Product Development. “Today’s acceptance builds upon our commitment by potentially offering patients a faster way to administer

Novartis lung cancer drug gets priority U.S. review

Novartis has won fast-track U.S. regulatory review for capmatinib (INC280) in a hard-to-treat form of lung cancer, the Swiss drugmaker said on Tuesday. Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer. "If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis," Novartis said in a statement. Source:

Ayushman Bharat ties up with NCG for standardised cancer care

Ayushman Bharat is closely working with the National Cancer Grid (NCG), a network of major cancer centres across the country, to ensure that those offering cancer surgeries, chemotherapy and radiation therapy and other procedures for cancer under the scheme follow a protocol. “NCG has tied up with the Ayushman Bharat and we are working on treatment protocols for various cancers. The idea is to tie up the reimbursements with adherence to guidelines,” said Dr. C. Pramesh, director of Tata Memorial Hospital (TMH) and convenor of the NCG. The NCG identifies itself as a union of cancer centres in the country which could provide uniform and high standards of cancer care, follow uniform evidence-based guidelines for management of patients, develop human resource adequately trained to fulfil the cancer healthcare needs of the entire nation and conduct collaborative clinical research of a high standard. According to Dr. Pramesh, work is on to create a software for the purpose. “This effort wil

Union health minister reiterates its commitment to implement NPCDCS

Union health minister of State Ashwini Kumar Choubey reiterated government’s commitment to implement National Programme for Prevention and control of cancer, diabetes, cardiovascular diseases and stroke (NPCDCS), with focus on strengthening infrastructure. It stated that the government will also renew its focus for human resource development, health promotion and awareness generation, early diagnosis, management and referral to an appropriate level institution for effective treatment. Choubey stated that to tackle the challenge of non communicable diseases (NCD), including cancer, 616 NCD clinics at district level and 3,827 NCD clinics at community health centre level have been set up under NPCDCS. Population level initiative has also been taken up for prevention, control and screening for common NCDs (diabetes, hypertension and common cancers such as oral, breast and cervical cancer has also been rolled out under the National Health Mission (NHM) in over 215 districts. To enhance the

Shilpa Medicare gets US FDA approval for generic Esbriet tablets

Shilpa Medicare has received US Food and Drug Administration (FDA) approval for pirfenidone tablets. The company received US FDA’s tentative approval for its ANDA, pirfenidone tablets, 267 mg and 801 mg, on January 30. The ANDA is filed as 'First to File' submission on NCE -1 date. Pirfenidone tablets is a generic equivalent of reference listed drug (RLD) Esbriet tablets of Hoffmann La Roche Inc used in the treatment of idiopathic pulmonary fibrosis. The annual US market for pirfenidone is approximately US$ 716.3 million, as per the IQVIA MAT Q2 2019 data. The company also received Central Drugs Standard Control Organization (CDSCO), New Delhi permission for manufacturing and marketing of lenvatinib capsules 4mg and 10mg in India. Lenvatinib capsules 4mg and 10mg is a generic equivalent of reference product, Lenvima, used in the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer and for the first

Global cancer burden expected to rise by 60% by 2040

The 20th anniversary of World Cancer Day (February 4, 2020), an annual event meant to raise cancer awareness and encourage governments, oncology societies, non-governmental organizations, businesses, and individuals to take action against the global impact of the disease. This has been formed in recognition to make progress in cancer prevention, provide better access to cancer care, and to have better outcomes of survival. The goals address impact on human life, human suffering and productivity. The emphasis is on providing access of quality cancer care to all. There is global rise in cancer burden in spite of progress in care in past 2 decades. The global cancer burden is estimated to grow to more than 29 million cases annually by 2040, assuming global rates in 2018 remain the same. Cancer is the leading or second-leading cause of death in 91 countries worldwide, and that the global cancer cases is expected to increase by 60% in 2040. That global rise in cancer burden is expected t

Trovagene announces positive data from phase 1b/2 trial of onvansertib plus FOLFIRI & Avastin for second-line treatment of KRAS-mutated mCRC

Trovagene, Inc, a clinical-stage, oncology therapeutics company targeting cancers that are both highly prevalent and in need of new effective treatment options including colorectal, prostate and acute myeloid leukemia, announced positive data from an ongoing phase 1b/2 clinical trial of onvansertib plus FOLFIRI and Avastin (bevacizumab) for second-line treatment of KRAS-mutated metastatic colorectal cancer (mCRC). The data demonstrate the pan-KRAS inhibitory effect of onvansertib. All five patients evaluable for efficacy assessment have shown a significant reduction in their KRAS mutational burden as measured by a simple blood test, which was subsequently confirmed by tumor regression visible on radiographic scans. Three patients had a >25% tumor shrinkage and one patient is now eligible for curative surgery, a clinically meaningful achievement, which is considered to be unprecedented in this patient population with only a 5% response to standard-of-care. The data was featured at

Roche seeks US FDA approval for Tecentriq in combo with Avastin to treat liver cancer

Roche announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted Breakthrough Therapy Designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing phase Ib trial. “Liver cancer is the most rapidly increasing cause of cancer-related death in the United States. In the IMbrave150 study, Tecentriq in combination with Avastin became the first treatment in more than a decade to improve overall survival compared with the current standar

Philips introduces new solutions in ultrasound, oncology and precision category in India

Royal Philips, a global leader in health technology, has introduced two new solutions in the ultrasound category such as Lumify (app-based high-quality portable ultrasound), MR – OR and RT oncology and wAssist (an innovative AI based solution that assists compliance to PNDT act and seamlessly integrates with medical practitioners standard workflow). The company highlighted its industry-leading AI driven enterprise imaging portfolio including innovative digital imaging platforms, advanced informatics and a suite of services at the 73rd Annual Conference of the Indian Radiological and Imaging Association (IRIA 2020). Commenting on the occassion, Jan Kimpen, global chief medical officer, said “Aligned with our focus of providing ‘Value-based’ care, we have extended our enterprise imaging portfolio through strategic investments in R&D and complementary acquisitions. Our new suite of imaging solutions embeds intelligence at every step of each operational workflow and disease management