CognitrexCancerDigest

AstraZeneca announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the Food and Drug Administration (FDA). In May 2017, Imfinzi was granted accelerated approval in the US based on promising tumour response rates and duration of response data from Study 1108, a phase I/II trial that evaluated the safety and efficacy of Imfinzi in advanced solid tumours, including previously treated bladder cancer. Continued approval was contingent on results from the DANUBE phase III trial in the 1st-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020. The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation. This withdrawal does not impact the indication outside the US and d...

Beta Drugs, a leading manufacturer of oncology products, announces the launch of Adsunib brand of Sunitinib . Adsunib is the first branded generic of Sunitinib with all dosage strength of 12.5/25/50 mg capsules, used for the treatment of Renal Cell Carcinoma ( RCC ), Gastro-Intestinal Tumor (GIST) & Pancreatic Neuroendocrine Tumor (pNET). Adsunib greatly reduces the monthly therapy cost of Sunitinib. It will significantly impact the lives of cancer patients who have thus far been denied access to this drug due to the high cost. Apart from Sunitinib, the company was the first to launch Axitinib and Lenvatinib that strengthens the company’s portfolio in Renal Cell Carcinoma therapy thus establishing it as a market leader in branded Oncology products. Recently, the company also launched ‘Adleap’ brand of Enzalutamide used for the treatment of prostate cancer which is the most economical brand in India. The lower financial burden will aid adherence. The company is poised for robust...

AstraZeneca could be looking at earlier use of its PARP inhibitor Lynparza in breast cancer, thanks to a new clinical trial win. When used after surgical removal of tumors, Lynparza topped placebo at fending off invasive disease and preventing death among patients with BRCA-mutated, high-risk, HER2-negative early breast cancer, AstraZeneca said Wednesday. An independent data monitoring committee said the phase 3 OlympiA trial had crossed the superiority bar for that primary endpoint and recommended investigators start analyzing specific data. And that means AstraZeneca could report the so-called "invasive disease-free survival" data earlier than expected, the company said. AZ said last week that it was expecting to take the OlympiA data to regulators in the second half of this year. The trial will continue to follow patients for secondary endpoints, such as Lynparza’s ability to prevent distant disease recurrence and—more importantly—whether it can help patients live longer...

The immuno-oncology data showdown between team Merck and team Bristol Myers Squibb in kidney cancer appears to have a winner in the eyes of at least one analyst. But that doesn’t mean the other party has lost the fight. After last week’s American Society of Clinical Oncology’s Genitourinary Cancers Symposium, Merck and Eisai’s Keytruda-Lenvima combo is the “clear choice” to elicit a rapid, durable response in most patients with previously untreated renal cell carcinoma, SVB Leerink analyst Daina Graybosch said in a Tuesday note. It’s a hard-fought win, with challengers including Keytruda’s pairing with Pfizer's tyrosine kinase inhibitor (TKI) Inlyta, Bristol Myers’ dual immunotherapy Opdivo and Yervoy, as well as Opdivo’s TKI combo with Exelixis’ Cabometyx. Graybosch reached the conclusion based on separate trials pitting those regimens against Pfizer’s standard treatment Sutent. In the Keynote-581 study, the Keytruda-Lenvima therapy triggered a response in 71% of patients, clearl...

NEW DELHI: Glenmark Pharma on Tuesday launched a generic kidney cancer treatment drug 'Sunitinib oral capsules' in India priced 96 per cent lower compared to the innovator brand. In a regulatory filing, Glenmark Pharma said it launched " SUTIB , the generic version of Sunitinib oral capsules to treat kidney cancer in India. The drug is launched at a MRP that is approximately 96 per cent lower than the MRP (maximum retail price) compared to the innovator brand, priced at Rs 7,000 (50 mg), Rs 3,600 (25 mg) and Rs 1,840 (12.5 mg) per month". Sunitinib is also approved by the US Food and Drug Administration ( USFDA ). Kidney cancer (renal cell carcinoma) is a disease of uncontrolled cell growth in the lining of small tubes in the kidney. Quoting Globocan 2020 report , Glenmark said there are close to 40,000 patients with renal cancer in India. Alok Malik, Group Vice President and Business Head, India Formulations, said, “Oncology is an important focus area for Glenmar...

In what could further boost Alembic Pharmaceutical's oncology business, its co-owned clinical-stage biopharmaceutical firm Rhizen Pharmaceuticals AG has bagged US Food and Drug Administration (USFDA) nod for an oral drug indicated in treating lymphoma. Umbralisib is indicated for treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. According to Alembic Pharma managing director Pranav Amin, what sets the drug apart is that the novel next generation oral inhibitor of phosphoinositide 3 kinase (PI3K) delta is the first new chemical entity discovered by Indian scientists to secure a US FDA approval. To be launched by early-next month in the US market, Umbralisib was discovered by Rhizen Pharma and subsequently licensed to Nasdaq-listed TG...

Pfizer Inc. announced that the US Patent and Trademark Office (USPTO) recently issued a US Patent Term Extension (PTE) certificate for Ibrance (palbociclib). The certificate extends the term of US Patent No. RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the US Food and Drug Administration (FDA). This extension does not include potential pediatric exclusivity. Ibrance is an oral inhibitor of CDKs 4 and 6, which are key regulators of the cell cycle that trigger cellular progression. In the US, Ibrance is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausa...

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. "Today's approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Gene and cell therapies have evolved from promising conce...