CognitrexCancerDigest

AstraZeneca announces positive high-level results from the TOPAZ-1 phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC). At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an improvement in OS in patients treated with Imfinzi plus chemotherapy versus chemotherapy alone. The combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints. Imfinzi plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. BTC is a group of rare and aggressive cancers that occu...

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, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] =1)as determined by an FDA-approved test. The approval is based on the phase 3 KEYNOTE-826 trial evaluating Keytruda plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab. In this patient population, Keytruda plus chemotherapy, with or without bevacizumab, demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy, with or without bevacizumab, in patients whose tumors exp...

The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's Verzenio (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of =20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population. "Over time, the collective results of the Verzenio clinical development programme have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, senior vice president,...

Merck, known as MSD outside the United States and Canada, announced that the phase 3 KEYNOTE-394 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib met its primary endpoint of overall survival (OS). The study found that treatment with Keytruda plus best supportive care resulted in a statistically significant improvement in OS compared with placebo plus best supportive care. KEYNOTE-394 also met its key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR), with statistically significant improvements for Keytruda compared with placebo. No new safety signals were observed. These results will be presented at an upcoming medical meeting. “Frequently diagnosed at an advanced stage, hepatocellular carcinoma has one of the highest mortality rates of solid cancers. Despite recent progress, there remains an unmet need for anti-PD-1 monotherapy after sorafenib...

Drug firm BDR Pharmaceuticals on Tuesday said it has launched generic Cabozantinib, used for the treatment of various types of cancer , and will bring the product in India in the next few days. Cabozantinib is used for the treatment of metastatic medullary thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma, BDR Pharma said in a statement. “Ensuring that all our patients have access to quality-produced, world-class treatment at a reasonable rate was the main reason for launching the drug in India,” BDR Pharmaceuticals, Business Development – Director, Raheel Shah said. The company, however, did not give any details about the cost of the drug. Cabozantinib is prescribed for treating patients with progressive, metastatic medullary thyroid cancer and as a second-line treatment for renal cell carcinoma apart from treating hepatocellular carcinoma, BDR Pharma said. The drug is available in the strengths of 20 mg, 40 mg and 60 mg, it added. Source:https://indianexpres...

MSN Labs has launched Cabolong, a branded generic of Cabozantinib, for the treatment of renal cell carcinoma. Cabolong is available in 20mg/40mg/60mg strengths at a pricing of below ₹10,000 for monthly treatment regimen with the highest strength. In contrast, the same therapy cost runs into lakhs (of rupees) with imported brands currently available in the market, the company said in a release on Thursday. MSN Labs said it has set up a dedicated oncology division, whose focus is on presenting a comprehensive range of affordable high quality, bio-equivalent generic oncology medicines to benefit patients in India. “Given the rising cancer incidence in our country and overwhelming treatment costs, launch of our dedicated oncology division demonstrates our unwavering commitment to patients’ health and economic well-being,” it said. Cabolong is manufactured at MSN Labs facility approved by global regulatory authorities such as US FDA and EU GMP, the company said. Source:https://www.thehindu....