CognitrexCancerDigest

Some of India’s leading oncologists have raised doubts over the utility of the tests like Oncotype DX genomic test, which assesses how a cancer is likely to respond to treatment, saying it increases the cost of treatment without yielding clear benefits while others have expressed their support.  In June several oncologists at the American Society of Clinical Oncology had validated the test that many experts claim can be used by women suffering from early-stage breast cancer to forgo chememotherapy  offering relief to several patients suffering from the toxic side effects of chemotherapy.   The test is offered by the United States-based genomic firm OncotypeIQ, which conducted a study, TailoreX, and reported that women who are diagnosed early with breast cancer and with a mid-range tumour score of 21 can skip chemotherapy. It said that the study found no improvement in disease-free survival when chemotherapy was added to hormone therapy in the group of trial patients....

  AstraZeneca Pharma  India on Thursday said it has received approval from the Indian drug regulator to market  Durvalumab , a  cancer treatment medicine , in the country.  The company has received import and market permission for Durvalumab from the Drug Controller General of India ( DCGI ), AstraZeneca Pharma India said in a statement.  The approval paves the way for the company to launch the product in the country, it added.  Durvalumab is indicated as a treatment option for patients with locally advanced, unresectable non-small cell lung Cancer (NSCLC) and metastatic urothelial carcinoma.  "The import and market permission for Durvalumab for unresectable stage III Non-Small Cell Lung Cancer (NSCLC) and locally advanced or metastatic urothelial carcinoma is a significant milestone for patients who have currently limited treatment options," AstraZeneca Pharma India Managing Director  Gagan Singh  said.  In India, around one third...

Patients with locally advanced cervical cancer had significantly increased disease-free survival (DFS) when treated with chemoradiation instead of neoadjuvant chemotherapy followed by radical surgery, a large randomized trial showed. The chemoradiation group had a median DFS rate of 76.7% compared with 69.3% for the patients assigned to neoadjuvant chemotherapy and surgery. Overall survival did not differ between treatment groups. Chemoradiation was associated with more late (≥24 months) toxicity, Sudeep Gupta, MD, of Tata Memorial Center in Mumbai, India, and co-authors reported in the  Journal of Clinical Oncology . "Our study has answered a long-standing and important clinical question in the treatment of patients with locally advanced cervical cancer. Concomitant chemoradiation using single-agent weekly cisplatin results in a significantly increased DFS rate compared with neoadjuvant chemotherapy followed by radical surgery in this patient population." Historica...

The US Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. The new approach, outlined on Saturday in a speech by FDA commissioner Dr. Scott Gottlieb at the American Society of Clinical Oncology (ASCO) meeting in Chicago, is part of an effort to remove regulatory barriers that drag out reviews of promising new cancer treatments. The new review process, which Gottlieb called a "real-time oncology review," is already being piloted in a number of applications for expanded use of already approved cancer drugs. Gottlieb believes the early peek at data would allow companies to address quality issues before submitting their the full application seeking approval. If the process succeeds, it will be expanded to applications for new cancer treatments. As part of the pilot program, FDA is trying out a shared application document that all...

Gobal drug giant Pfizer  recently announced today that the U.S. Food and Drug Administration has accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. Talazoparib is an investigational anti-cancer medicine called a PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies suggest that talazoparib is highly potent and has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. Talazoparib is currently being evaluated in advanced gBRCAm breast cancer and early triple negative breast cancer as well as DNA damage repair (DDR)-deficient prostate cancer and in combination with immunotherapy in various solid tumor types. Talazoparib has not been approved by any regulatory authorities for the treatment of any disease. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherap...

Biocon Ltd and partner Mylan NV on Tuesday announced the grant of approval by the US Food and Drug Administration (FDA) for their cancer drug Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer. Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the US, which Mylan hopes to launch in the coming weeks. Fulphila represents the first alternative, more affordable treatment option to Neulasta for oncology patients, the companies said in a statement, adding that a suite of patient services also will be available at launch to further support patients and caregivers with treatment. "FDA’s approval of this product, as w...

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for XALKORI (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. MET is a trans membrane tyrosine receptor kinase which is expressed in several types of cells. In patients with NSCLC, MET exon 14 alterations occur in approximately three percent of NSCLC tumors. Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma, divided into ALK-positive or ALK-negative disease. Despite the activity of chemotherapy, many patients with ALCL relapse or require alternative treatment approaches. “Biomarker-driven...