Showing posts from March, 2021

Alkem Laboratories ties with Tata Memorial Hospital to establish cancer care facility in Bihar

Alkem Laboratories Limited has agreed to partner with Tata Memorial Centre (TMC) to establish an advanced Radiotherapy Facility as a part of the Homi Bhabha Cancer Hospital and Research Center, Muzaffarpur. As part of Alkem's CSR activity, Alkem has sanctioned the purchase of 2 most advanced versions of the teletherapy and brachytherapy units for this facility. This facility being developed as a spoke model shall also provide chemotherapy, minor operation, basic laboratory, treatment planning, etc. To decentralize the cancer care further, Alkem and TMC have collaborated to also establish 3 mini cancer units in the following cities of Bihar namely Buxar, Jehanabad and Bhagalpur. These centers will connect cancer patients of those districts by telemedicine to HBCHRC, Muzaffarpur. In addition, these centers will work with the district administration on community activities such as cancer awareness and screening. Radiotherapy is an essential part of any cancer hospital. As per WHO and

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death

Roche withdraws Tecentriq for bladder cancer; pullback comes amid FDA review

The FDA’s crackdown on drugs that aren’t meeting approval requirements has now hit Roche. The Swiss pharmaceutical giant announced Monday that it is pulling its blockbuster drug Tecentriq from the U.S. as a bladder cancer treatment. The withdrawal comes more than three years after the Roche drug failed a confirmatory clinical study. The accelerated approval pathway provides a faster path to the market for drugs treating diseases that have few treatment options. But as a condition for keeping that approval, companies must conduct additional clinical tests to confirm a drug’s benefit. Drugs that fail to demonstrate such benefit can have their approvals revoked. Roches’ withdrawal of Tecentriq is voluntary, but the company said the decision was made after consulting with the FDA. The agency has been conducting an industry-wide review of therapies that got quick entry to the market but have fallen short of the requirements to retain approval status. The FDA’s review has led to voluntary w

Novartis' Canakinumab Fails To Improve Survival In Late-Stage Lung Cancer Trial

Novartis AG (NYSE: NVS ) reported data from the Phase 3 CANOPY-2 study evaluating canakinumab (ACZ885) in advanced or metastatic non-small cell lung cancer (NSCLC). The study did not meet the primary endpoint of overall survival (OS). The trial evaluated canakinumab plus chemotherapy agent docetaxel in adults with NSCLC whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy. Canakinumab development program continues with two Phase 3 CANOPY trials, evaluating the antibody in first-line and adjuvant settings. Novartis and CANOPY-2 investigators will analyze the study data and are expected to submit the findings for presentation at an upcoming medical meeting. Canakinumab is a human monoclonal antibody that could enhance anti-tumor immune response and reduce tumor cell proliferation, survival, and invasiveness. Source:

Merck inks Keytruda deal with Surface Oncology; Rocket Pharmaceuticals gets expedited review of gene therapy for rare pediatric disease

The pharma took the wraps off a collaboration deal on Tuesday to pair Keytruda with Surface Oncology’s IL-27 targeting antibody SRF388. The combo will be studied as a component of Surface’s Phase I study for SRF388 in patients with solid tumors, specifically those with liver and kidney cancer. Surface has identified specific tumor types in which it believes IL-27 plays a role in resistance to checkpoint inhibitors. The company says it got the initial Phase I results it was looking for back in November, and is now headed into the expansion stage of the study. The initial results are expected to be read out in the first half of this year. “Surface is the only company with clinical-stage IL-27 research and we believe that this cytokine may play an important role in resistance to anti-PD-1 treatment,” Rob Ross, incoming Surface CEO, said in a statement. Keytruda, which raked in $14.4 billion in net sales last year, has racked up a variety of indications from melanoma to cervical cancer. Bu

Pfizer’s Lorbrena gets US FDA approval to treat ALK-positive non-small cell lung cancer

The US Food and Drug Administration (FDA) approved Pfizer Inc’s supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an US FDA-approved test. The US FDA action also converts the 2018 accelerated approval to full approval. The application was approved under the US FDA’s Real-Time Oncology Review (RTOR) pilot program. “For more than a decade, Pfizer has been a pioneer in delivering biomarker-driven therapies and addressing the diverse and evolving needs of people with non-small cell lung cancer,” said Andy Schmeltz, global president, Pfizer Oncology. “Lorbrena has been a transformative medicine for people with ALK-positive advanced NSCLC, and this US FDA approval in the first-line setting means that we can now extend hope t

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R