Showing posts from May, 2021

BDR Pharma launches the first generic RUCAPARIB to treat advanced ovarian and prostate cancers in India

BDR Pharmaceutical launched BDPARIB (RUCAPARIB) to treat advanced ovarian and prostate cancers today. BDPARIB is the first affordable generic in the India available in the form of a tablet, with the cost of therapy less expensive than any existing drugs in the market. RUCAPARIB is an oral, small-molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2, and 3 used as a monotherapy and in conjunction with other anti-cancer agents in several tumor forms, including ovarian and prostate cancers. It has played a significant role in treating ovarian cancer patients with BRCA mutation (germline or somatic) associated with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapy. "BDPARIB was developed to treat patients living with advanced ovarian and prostate cancer with an unmet need. This research's positive results through the ARIEL3 study & TRITON2 study are highly promising and indicate that the benefits exte

Lupin receives $50 million from Boehringer Ingelheim for achievement of key milestones

Drug major Lupin on Thursday said it has received payment of USD 50 million (around Rs 363.5 crore) from Germany-based Boehringer Ingelheim for achievement of key milestones by its novel cancer drug, a potential target therapy for patients with difficult-to-treat cancers . In a regulatory filing, Lupin announced "the achievement of key milestones for Lupin's MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers." In 2019, Lupin and Boehringer Ingelheim had inked a licensing, development and commercialisation agreement for Lupin's novel oncology compound. "As part of the agreement, Lupin has received payment of USD 50 million from Boehringer Ingelheim for achievement of key milestones," Lupin said in the regulatory filing. Lupin said its new chemical entity research team is focused on building a pipeline of highly differentiated and

Zydus launches Ujvira, a breakthrough in Breast Cancer treatment

Zydus Cadila, a global innovation driven healthcare company, launched Trastuzumab Emtansine, the first Antibody Drug Conjugate (ADC) biosimilar and a highly effective drug for treating both Early and Advanced HER2 positive Breast Cancer, under the brand name 'Ujvira'. HER2 positive Breast Cancer is considered an aggressive form and constitutes 20 to 25% of all Breast Cancers. In a step that can significantly reduce treatment cost by almost 80%, the drug is being offered at Rs. 32495 for a 100 mg vial. The current MRP of existing Trastuzumab Emtansine drug is Rs. 1,59,225 for 100 mg vial. Ujvira will be available in two strengths, 100 mg and 160 mg. Speaking on this milestone, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited said, "The launch of Ujvira reinforces the innovation capabilities that India has to be able to create complex therapies like ADCs and Zydus' ongoing commitment to offer breakthroughs backed by science and innovation. This research br

US FDA approves Bristol Myers’ Opdivo as adjuvant treatment of completely resected esophageal or GEJ cancer in patients who have received n eoadjuvant CRT

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has approved Opdivo (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval is based on results from the phase 3 CheckMate -577 trial that evaluated Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection. In the trial, among patients who received Opdivo, median disease-free survival (DFS) was twice as long as in those who received placebo (22.4 months [95% Confidence Interval [CI]: 16.6 to 34.0] compared to 11.0 months [95% CI: 8.3 to 14.3]). Opdivo reduced the risk of disease recurrence or death by 31% compared to placebo (Hazard Ratio [HR] 0.69; 95% CI: 0.56 to 0.85; P=0.0003). In an exploratory analys

Takeda to present positive primary analysis from phase 2 OPTIC trial of Iclusig to treat chronic-phase chronic myeloid leukemia at ASCO meeting

Takeda Pharmaceutical Company announced that primary analysis data from the phase 2 OPTIC (optimizing ponatinib treatment in CML) trial will be presented during an oral session at the virtual 57th American Society of Clinical Oncology (ASCO) Annual Meeting, and as an oral session at the virtual 26th European Hematology Association (EHA) Annual Meeting. The OPTIC trial is a randomized, open-label study prospectively evaluating response-based dosing regimens of Iclusig (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. The OPTIC trial, which evaluated treatment in patients with resistant disease, with and without mutations, met its primary endpoint. The study demonstrates that the optimal benefit-risk profile for Iclusig in patients with CP-CML is achieved with a daily start

Roche aims Tecentriq at early lung cancer after data shows benefit

Immunotherapy showed for the first time it can help early-stage lung cancer patients survive longer without their disease returning, according to data released on Wednesday, a potential turning point for such drugs to be used before tumours spread. The drug, Tecentriq from Switzerland's Roche , works like other immunotherapies including Merck's Keytruda and Opdivo from Bristol Myers Squibb, helping take the brakes off the immune system so it can attack tumours. While regarded as an important treatment breakthrough, this class of drugs has so far been largely deployed against advanced lung cancer that has metastasized, attacking other organs including the brain. This new data, released at the 2021 American Society of Clinical Oncology (ASCO) annual meeting, demonstrates that deploying Tecentriq earlier, when surgery is still possible, can help delay recurrence of cancer, scientists said. "Though surgery can cure some patients with early-stage lung cancer, disease recurr

US FDA grants priority review status for Merck & Eisai’s Keytruda plus Lenvima applications for advanced RCC and advanced endometrial carcinoma

Merck, known as MSD outside the United States and Canada, and Eisai Inc. announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. The first set of applications (a supplemental Biologics License Application [sBLA] for Keytruda and a supplemental New Drug Application [sNDA] for Lenvima) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal phase 3 CLEAR study (KEYNOTE-581/Study 307). The second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surg