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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Roche reports positive Phase II results for experimental eye drug
Lampalizumab
Roche reports positive Phase II results for experimental eye drug
Lampalizumab, an experimental eye drug from Roche, has helped slow down the progression of an advanced form of age-related macular degeneration (AMD) in a Phase II study, the company announced this week.
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SEE ALSO
Lampalizumab effective in Phase II clinical trial for macular degeneration
Roche’s new drug for age-related macular degeneration, lampalizumab, showed effective in slowing the progression of AMD in patients with advanced disease, shrinking the area of geographic atrophy by 20%. Read More >>
Lampalizumab (INN) is a humanized monoclonal antibody designed for the treatment of geographic atrophy secondary to age-related macular degeneration. It binds to CFD.[1][2]
This drug was developed by Genentech/Roche.
References
India seeks to cancel Roche cancer patent
India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act
India’s health ministry is looking to revoke Roche’s breast cancer drug’s patent in public interest using powers under section 66 of the Indian Patents Act India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act Related Articles Oramed gets Japanese patent for protein delivery Cipla wins patent case against Roche Alchemia cancer drug gets US patent protection Alchemia gets US patent for oncology platform technology New Delhi: India’s health ministry has asked for a cancellation of patent to Roche’s breast cancer medicine Trastuzumab, using a rarest-of-the-rare provision in the Indian Patents Act.
Read more at: http://www.biospectrumasia.com/biospectrum/news/192436/india-seeks-cancel-roche-cancer-patent#.UfXtuaI3CSo
Roche may bid for Alexion, gets Erivedge EU approval
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Erivedge , Vismodegib
The molecule also is known as GDC-0449 and RG3616.
read all at
http://pharmatimes.com/Article/13-07-15/Roche_may_bid_for_Alexion_gets_Erivedge_EU_approval.aspx
Vismodegib works by interfering with the membrane protein Smoothened, which provides positive signals to the Hh pathway. At present, there are no FDA-approved drugs targeting Hh signaling, although the pathway is the focus of investigation in a variety of cancers.
Meantime, Roche has obtained conditional European approval for Erivedge (vismodegib) for the treatment of adults with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy.
The Basel-based group noted that the approval makes Erivedge, a capsule taken once-a-day, the first licensed medicine for patients in the European Union “with this disfiguring and potentially life-threatening form of skin cancer”. Chief medical officer Hal Barron said the green light “is great news for patients with advanced basal cell carcinoma, who previously had no medicines to treat their disease”, adding that Erivedge substantially reduced tumour size in patients in clinical trials.
Under the conditional approval, Roche will provide additional data from an ongoing global safety study. Erivedge was approved by the US Food and Drug Administration in January 2012 following a priority review.
Vismodegib (trade name Erivedge) is a drug for the treatment of basal-cell carcinoma(BCC). The approval of vismodegib on January 30, 2012, represents the first Hedgehog signaling pathway targeting agent to gain U.S. Food and Drug Administration (FDA) approval.[1] The drug is also undergoing clinical trials for metastatic colorectal cancer,small-cell lung cancer, advanced stomach cancer, pancreatic cancer, medulloblastomaand chondrosarcoma as of June 2011.[2] The drug was developed by the biotechnology /pharmaceutical company Genentech, which is headquartered at South San Francisco, California, USA.
Vismodegib is indicated for patients with basal cell carcinoma (BCC), which has metastasized to other parts of the body, relapsed after surgery, or cannot be treated with surgery or radiation.[3]
Hedgehog Activation.
The substance acts as a cyclopamine-competitive antagonist of the smoothened receptor (SMO) which is part of the hedgehog signaling pathway.[2] SMO inhibition causes the transcription factors GLI1 and GLI2 to remain inactive, which prevents the expression of tumor mediating genes within the hedgehog pathway.[4] This pathway is pathogenetically relevant in more than 90% of basal-cell carcinomas.[5]
Ligand-dependent Hedgehog signaling.
- “Vismodegib, First Hedgehog Inhibitor, Approved for BCC Patients”.
- Molecule of the Month. June 2011.
- “FDA approves Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma”.
- “Vismodegib (GDC-0449) Smoothened Inhibitor – BioOncology”.
- H. Spreitzer (4 July 2011). “Neue Wirkstoffe – Vismodegib”. Österreichische Apothekerzeitung (in German) (14/2011): 10.
Vismodegib is Hedgehog (Hg) path inhibitors. Pka = 3.8 (pyridinium cation); soluble 0.1μg/mL (pH = 7), 0.99mg/mL (pH = 1), logP = 2.7. Vismodegib can be synthesized by the following route:
Roche files next-generation Rituxan in USA, EU
Roche has filed obinutuzumab on both sides of the Atlantic to treat chronic lymphocytic leukaemia.May 16, 2013
read all at
http://www.pharmatimes.com/Article/13-05-16/Roche_files_next-generation_Rituxan_in_USA_EU.aspx
CHEMICAL NAMES
FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis
tocilizumab
April 30, 2013
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two years of age and older with active disease. Actemra can be given alone or in combination with methotrexate (MTX) in people with PJIA.
PJIA is a form of juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis, a chronic disease of childhood.1 JIA affects approximately 100 in every 100,000 children2 of which PJIA accounts for around 30 percent.3 PJIA is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.3
“Polyarticular juvenile idiopathic arthritis is a rare debilitating condition in children that worsens over time,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are pleased to offer Actemra to doctors and parents of children aged two or older to help improve the signs and symptoms of this often painful disease.”
This FDA approval marks the second Actemra indication in children and is the first FDA approval for the treatment of PJIA in approximately five years. The EU Committee for Medicinal Products for Human Use (CHMP) also announced a positive opinion for this indication on Friday, April 26. The final approval from the European Medicines Agency (EMA) is expected this summer.
The expanded indication for Actemra was based on positive data from the Phase III CHERISH study in children with PJIA, which had an open label phase, followed by a randomised double-blind placebo-controlled withdrawal phase. The study demonstrated that patients treated with Actemra experienced clinically meaningful improvement in signs and symptoms of PJIA. A total of 91 percent of patients taking Actemra plus MTX and 83 percent of patients taking Actemra alone achieved an ACR 30 response at week 16 compared to baseline. In the randomised double-blind placebo-controlled withdrawal phase of the trial, Actemra-treated patients experienced significantly fewer disease flares compared to placebo-treated patients [26 percent (21/82) vs. 48 percent (39/81)].
The safety data collected to date for Actemra in PJIA patients is consistent with that observed in previous studies in Actemra-treated patients.4 In the CHERISH study, infections were the most common adverse events (AEs) and serious adverse events (SAEs) over 40-weeks. Laboratory abnormalities known to occur with Actemra were also observed in this study, including decreases in white blood cell counts and platelet counts, and elevation in ALT and AST liver enzyme levels.
About Actemra (tocilizumab)
Actemra is the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). The extensive Actemra clinical development programme included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, Actemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older who have responded inadequately to previous therapy with MTX.
Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Tocilizumab (INN, or atlizumab, developed by Hoffmann–La Roche and Chugai and sold under the trade names Actemra and RoActemra) is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of RA in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer.
The European Medicines Agency (EMA) has approved Roche’s PERJETA (pertuzumab) for patients with previously untreated HER2-positive metastatic breast cancer (mBC)
The structure of HER2 and pertuzumab
march 4, 2013
Pertuzumab (also called 2C4, trade name Perjeta) is a monoclonal antibody. The first of its class in a line of agents called “HER dimerization inhibitors”. By binding to HER2, it inhibits the dimerization of HER2 with other HER receptors, which is hypothesized to result in slowed tumor growth.[1] Pertuzumab received US FDA approval for the treatment of HER2-positive metastatic breast cancer on June 8, 2012.[2] Pertuzumab was developed at Genentech and is now owned by Roche which acquired Genentech in 2009.
Clinical trials
Early clinical trials of pertuzumab in prostate, breast, and ovarian cancers have been met with limited success.[3]
The dosage of pertuzumab used in the pivotal phase III CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab) trial was as follows: IV 840 mg loading dose followed by IV 420 mg every three weeks.[4]
The pharmacokinetics of intravenous pertuzumab appear to be unaffected by age and no drug-drug interaction has been reported with docetaxel. The pharmacokinetics and pharmacodynamics of pertuzumab were summarized in a Feb 2012 review by Gillian Keating.[4]
The combination of pertuzumab plus trastuzumab plus docetaxel, as compared with placebo plus trastuzumab plus docetaxel, when used as first-line treatment for HER2-positive metastatic breast cancer, significantly prolonged progression-free survival, with no increase in cardiac toxic effects in the randomized, double-blind, multinational, phase III CLEOPATRA trial.[5]
Intravenous pertuzumab is currently being evaluated in patients with breast cancer in the following trials: MARIANNE (advanced breast cancer), NEOSPHERE (early breast cancer), TRYPHAENA (HER2-positive stage II/III breast cancer) and APHINITY (HER2-positive nonmetastatic breast cancer).[4]
References
- de Bono, Johann S.; Bellmunt, J; Attard, G; Droz, JP; Miller, K; Flechon, A; Sternberg, C; Parker, C et al. (20 January 2007). “Open-Label Phase II Study Evaluating the Efficacy and Safety of Two Doses of Pertuzumab in Castrate Chemotherapy-Naive Patients With Hormone-Refractory Prostate Cancer”. Journal of Clinical Oncology 25 (3): 257–262. doi:10.1200/JCO.2006.07.0888. PMID 17235043.
- “FDA Approves Perjeta (Pertuzumab) for People With HER2-Positive Metastatic Breast Cancer” (Press release). Genentech. Retrieved 2012-06-09.
- Genentech press release – May 15, 2005
- Keating GM. Pertuzumab: in the first-line treatment of HER2-positive metastatic breast cancer. Drugs 2012 Feb 12; 72 (3): 353-60.Link text
- Baselga J, Cortés J, Kim SB, and the CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012 Jan 12; 366 (2): 109-19. Link text
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