Showing posts from May, 2020

Shilpa Medicare launches anti-cancer drug - IBRUSHIL

Shilpa Medicare has launched the Indian branded generic lbrutinib, an anti-cancer drug with a brand name IBRUSHIL. IBRUSHIL is available in 140 mg capsules in packs of 30's capsules and 120's capsules. IBRUSHIL is used to treat patients suffering from Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphomas (MCL) and other related cancers. This new Leukemia drug is more effective and easier to use. IBRUSHIL attacks cancer cells without damaging normal cells, this causing fewer side effects. The drug is taken once daily, than the standard treatment that requires multiple injections by the patients. Current, monthly therapy cost of innovator is approximately Rs. 4.36 lakh, with the launch of IBRUSHIL monthly cost of treatment will be reduced drastically to Rs. 34920/- as monthly therapy cost. The latest drug follows the successful launch of Lenvatinib "LENSHIL" and Dasatinib "DASASHIL" in India market. Source: https://www.busines

U.S. FDA Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer

Takeda Pharmaceutical Company Limited  (TSE:4502/NYSE:TAK)  today announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the first-line setting. ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations. “We’re extremely proud of the positive results ALUNBRIG has shown for newly diagnosed ALK+ NSCLC patients, particularly those with brain metastases,” said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. “Through a robust clinical development program and ongoing investigations across the NSCLC treatment landscape, Takeda is committed to uncovering solutions for people living with devastating forms of lung cancer in need of new options. We believe this

US FDA approves Lynparza for HRR gene-mutated metastatic castration-resistant prostate cancer

AstraZeneca and MSD Inc, announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval by the US Food and Drug Administration (FDA) was based on results from the phase III PROfound trial. Prostate cancer is the second-most common cancer in men and despite an increase in the number of available therapies for men with mCRPC, five-year survival remains low. HRR gene mutations occur in approximately 20-30% of patients with mCRPC. MahaHussain, one of the principal investigators of the PROfound trial and deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University said, “Prostate cancer has lagged behind other solid tumours in the era of precision medicine. I am thrilled by the approval of Lynparza which now brings a molecularly targeted treatment to men with HRR gene-mutated metastatic castration-resistant prostate c

Covid impact: 5.8 lakh elective surgeries postponed in India

BENGALURU : More than 5.8 lakh elective surgeries have been delayed or cancelled in India due to the lockdown to prevent the spread of covid-19, according to an international research consortium. In March, the Union health ministry had urged hospitals to postpone elective surgeries to reduce the risk of patients being exposed to the novel coronavirus. The study’s findings were recently published in British Journal of Surgery. The CovidSurg Collaborative, a research network of surgeons and anaesthetists in 77 countries, including India, has estimated that 5,05,800 non-emergency surgeries, 51,100 cancer surgeries, and 27,700 obstetric surgeries could have been delayed across India during the three-month period before and after the peak of the viral outbreak. Doctors say the pace of normal surgical procedures should now return to normal, albeit with proper precautions to clear the mounting backlog. Dr P Raghu Ram, president of The Association of Surgeons of India, stressed on the need to

AstraZeneca, Daiichi Sankyo Get USFDA Breakthrough Therapy Status For Lung Cancer Drug Enhertu

AstraZeneca and Daiichi Sankyo Company, Limited has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy. NSCLC is the most common type of lung cancer, and the prognosis is particularly poor for patients with metastatic disease as only about 6-10% will be alive five years after diagnosis. Approximately 2-4% of patients with NSCLC have a HER2 mutation. The Food and Drug Administration (FDA)'s BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines. José Baselga, Executive Vice President, R&D

Boehringer Ingelheim expands immuno-oncology portfolio by acquiring Northern Biologics’ preclinical cancer antibody pipeline

Boehringer Ingelheim announced the acquisition of Northern Biologics Inc., a wholly owned subsidiary of Northern LP. By acquiring this entity, which focuses on therapeutic antibodies targeting the tumor microenvironment, Boehringer Ingelheim is now positioned at the forefront of the stromal biology space - an emerging area in cancer immunology. The seller will retain the Northern Biologics name and will continue to drive certain preclinical efforts on one of the programs, while BoehringerIngelheim will be responsible for clinical, regulatory and commercial development of the acquired programs. The total transaction includes an upfront payment, milestones and other consideration payments. The first programme, now in late preclinical development, is an antibody inhibitor of Periostin, a secreted matricellular protein overexpressed in the immunosuppressive stroma microenvironment of many solid tumor types. Targeting these stromal cells can help turn previously ‘cold’ tumors – non-reactiv

Merck announces positive results from phase KEYNOTE-355 trial of anti-PD-1 therapy Keytruda in combo with chemotherapy to treat mTNBC

Merck announced positive results from the phase 3 KEYNOTE-355 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (mTNBC). In patients whose tumors expressed PD-L1 with Combined Positive Score (CPS) =10, Keytruda plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 35% (HR = 0.65 [95% CI, 0.49-0.86], p=0.0012) and improving PFS to a median of 9.7 months compared to 5.6 months for those receiving chemotherapy alone. In patients whose tumors expressed PD-L1 with CPS =1, Keytruda plus chemotherapy improved PFS versus chemotherapy alone (median PFS = 7.6 months versus 5.6 months; HR = 0.74 [95% CI, 0.61-0.90], p=0.0014), however these results did not meet statistical significance. As previously announced, the trial will continue without cha

US FDA approves Lilly’s Retevmo to treat adult patients with advanced RET-driven lung & thyroid cancers

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) approved Retevmo (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 phase 1/2 trial's endpoints of objective response rate (ORR) and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory tr

Zydus Cadila launches generic prostate cancer drug at nearly 70% less price in India

Drug firm  Zydus Cadila  on Friday said it has launched generic Enzalutamide capsules used for the treatment of  prostate cancer  which costs nearly 70 per cent less than the currently available similar products in India. The company's product under the brand name 'Obnyx' is priced at Rs 23,980 per month. The current maximum retail price (MRP) of Enzalutamide drug ranges from Rs 70,000 to 80,000 for a monthly therapy, Zydus Cadila said in a statement. This price reduction will benefit many prostate cancer patients to adhere to the treatment, it added. "Our aim is to make a preferred choice of therapy like Obynx available and more accessible to people suffering from cancer. Bridging these unmet gaps comes from our patient-first approach," Zydus Cadila MD Sharvil Patel told . Enzalutamide is a preferred option among  patients  with significant liver, heart and kidney diseases which is very common in the elderly men. It has an advantage of being taken through oral