Showing posts from June, 2020

Roche’s phase III IMpassion031 study of Tecentriq in combo with chemotherapy to treat early triple-negative breast cancer meets primary endpoint

Roche announced that the phase III IMpassion031 study, evaluating Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression. “Triple-negative breast cancer remains an aggressive disease with high rates of recurrence,” said Levi Garraway, M.D, Ph.D, Roche’s chief medical officer and head of global product development. “Our goal in treating TNBC at its earliest stages is to provide people with the best chance for a future cure. Adding Tecentriq to chemotherapy now has the potential to help women with TNBC at multiple different stages of the disease.” In the study, fewer pati

Roche Pharma India expands partnership with Cipla for key oncology medicines

Drug firm Roche Pharma India on Thursday said it has expanded its partnership with domestic pharma major Cipla to further improve access to its key oncology medicines in India. Roche Pharma India has signed a "distribution agreement with Cipla to expand the scope of the partnership to include, marketing and distribution of its trademark oncology drugs - trastuzumab (Herclon), bevacizumab (Avastin) and rituximab (Ristova) in India," the company said in a statement. The two companies had previously entered into a similar agreement in February 2018 for promotion and distribution of tocilizumab (Actemra) and other products, it added. "We have been working as a partner with Cipla for some of our products... We hope to extend the same support to patients in India through this new agreement,” Roche Products (India) general manager V Simpson Emmanuel said. This deal will ensure that the company's focus on providing Roche innovations in India remains steadfast in this

US FDA grants accelerated approval to Jazz Pharma’s Zepzelca to treat metastatic small cell lung cancer

Jazz Pharmaceuticals plc, a global biopharmaceutical company, announced along with its partner PharmaMar that the US Food and Drug Administration (US FDA) approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The US FDA approval of Zepzelca is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with SCLC who had disease progression after treatment with platinum-based chemotherapy. The data, which appeared in The Lancet Oncology May 2020 issue, showed that in patients with relapsed SCLC, Zepzelca demonstrated an ORR of 3

With latest Keytruda approval, Merck beats Bristol Myers to a new immunotherapy target

The Food and Drug Administration has approved the Merck & Co. immunotherapy Keytruda for people whose tumors have a certain number of genetic mutations — a measure called high tumor mutational burden — no matter where their cancer originated. The decision marks the second so-called tissue agnostic approval for Keytruda, which made history in 2017 when the Food and Drug Administration cleared it for patients whose tumors have one of two genetic problems — microsatellite instability-high or mismatch repair deficiency. Other tissue agnostic approvals for Bayer's Vitrakvi and Roche's Rozlytrek have since followed. Tumor mutational burden, or TMB, has been studied in multiple immunotherapy trials, but Merck's approval marks its first validation by a drug regulator. Merck rival Bristol Myers Squibb had focused on TMB in developing its immunotherapy combination for lung cancer, which was approved last month. But the FDA didn't mention the marker in its decision. Wednesd

GSK pumps $120M into partnership with Ideaya in oncology precision medicine play

One of the largest drugmakers in the U.K. is partnering with a U.S.-based biotech company focused on an emerging area of cancer therapy whereby drugs kill cancer cells by targeting multiple genes. London-based GlaxoSmithKline  said  Tuesday that it would partner with South San Francisco, California-based Ideaya Biosciences on research into synthetic lethality, whereby a drug kills a cancer cell by knocking down two genes in combination, whereas the cell would survive if only one of those genes were targeted. Under the deal,  GSK  is paying  Ideaya  $100 million upfront, along with making a $20 million equity purchase of the company’s stock and a potential $50 million option exercise fee for one of its programs. Ideaya would also be entitled to receive preclinical, clinical and sales milestones. Shares of Ideaya were up more than 30% on the Nasdaq in late-morning trading Tuesday. Shares of GSK were up more than 1% on the London and New York stock exchanges. The partnership inv

Clinical trial of CAR-T technology to treat blood cancer to begin soon

A team of researchers from the Indian Institute of Technology-Bombay (IIT-B) and doctors from the Tata Memorial Centre (TMC), Mumbai, will soon start the first clinical trial of indigenously developed CAR-T technology in the country for the treatment of blood cancer. The central government’s National Biopharma Mission (NBM) -Biotechnology Industry Research Assistance Council (BIRAC) has now approved ₹18.96 crore to the team for conducting a first-in-human phase-1/2 clinical trial of the CAR-T cells. The novel CAR-T cells will act are drugs that were indigenously developed at IIT Bombay by Rahul Purwar, a professor from the Bioscience and Bioengineering (BSBE) department. The design, development, and extensive pre-clinical testing was carried out in a laboratory with clinical inputs from Dr Gaurav Narula, professor of Pediatric Oncology and Health Sciences, and his team from TMC. The team has filed for national and international patents for the product. While the CAR-T cell technology

India’s only virtual platform for Cancer Care gets global recognition, India’s leading digital platform for cancer care, recently received global recognition for its advanced technology platform “Online Cancer Patient Assistance Pathway” (OCPAP™) at the recently held annual meeting of the American Society of Clinical Oncology (ASCO) in May 2020. A concordance study comparing the treatment guidance provided by the OCPAP™ platform against that provided by a panel of senior oncologists was found to provide the right treatment guidance to patients with very high accuracy. The Study was presented by Dr Amit Jotwani, co-founder and Chief Medical Officer of As per the Global Survey of Clinical Oncology Workforce 2018, for every 10,000 cancer patients, there are only 1 to 5 trained oncologists in developing countries like India. Scarcity of oncologists and lack of accessibility to healthcare are key factors that contribute to the high mortality-incidence ratio of 0.68. In light of these staggering statistics,’s concordance study o

AstraZeneca, Accent Therapeutics collaborate to develop transformative therapeutics targeting RMPs to treat cancer

AstraZeneca will collaborate with Accent Therapeutics to discover, develop and commercialise transformative therapeutics targeting RNA-modifying proteins (RMPs) for the treatment of cancer. This collaboration focuses on targeting RMPs, proteins that control many aspects of RNA biology and represents a new approach for addressing the process disruptions that can lead to cancer and can cause resistance to medicines. It combines AstraZeneca’s industry leading expertise bringing forward novel oncology medicines with Accent’s expertise as a leader in the biology, target identification and drug discovery of RMP-targeting therapies. José Baselga, executive vice president, oncology R&D, AstraZeneca said: “The promise of RMP inhibition is a compelling area of exploration for AstraZeneca. With this collaboration, we will seek to identify novel targets and unlock the full potential of our medicines. We believe that the Accent team’s expertise in RNA-modifying protein biology and drug disco

FDA approves Roche immunotherapy cocktail in liver cancer

The immunotherapy Tecentriq in combination with drug Avastin will give speedy access to cancer patients Swiss drugmaker Roche said that the US Food and Drug Administration (FDA) approved its immunotherapy Tecentriq in combination with its drug Avastin for the most common kind of liver cancer. The Tecentriq-Avastin mix for unresectable or metastatic hepatocellular carcinoma was approved under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative aimed at speedier access for patients, Roche said.  The American Cancer Society estimated that more than 42,000 Americans will be diagnosed with liver cancer this year. Source:

US FDA approves Lilly's Cyramza to treat metastatic EGFR-mutated NSCLC

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved Cyramza (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, Cyramza has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers. Cyramza plus erlotinib is the first and only FDA-approved anti-VEGFR/EGFR TKI combination therapy for metastatic EGFR-mutated NSCLC. This approval is based on the efficacy and safety from the global, randomized, placebo-controlled phase 3 RELAY trial. In the RELAY study, Cyramza, a VEGF receptor 2 antagonist, in combination with erlotinib, a globally approved EGFR-targeting tyrosine kinase inhibitor (TKI), demonstrated a statistically significant and clinically meaningful improvement in progression-f