Bevacizumab/Erlotinib Combo Approved in Europe for NSCLC

Excerpt:

“The European Commission approved bevacizumab (Avastin) in combination with erlotinib (Tarceva) as a frontline treatment for patients with unresectable advanced, metastatic, or recurrent EGFR-mutant non–small cell lung cancer (NSCLC).

“The approval was based on findings from the phase II JO25567 study, which showed a 46% reduction in the risk of progression or death with the combination versus single-agent erlotinib. The median progression-free survival (PFS) with the addition of bevacizumab was 16 versus 9.7 months with erlotinib alone (HR, 0.54; 95% CI, 0.36-0.79; P = .0015).

“ ‘The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,’ Sandra Horning, MD, chief medical officer and Global Head of Product Development at Roche, the company developing the combination, said in a statement. ‘This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond 1 year, representing important progress for a group of patients who typically face a poor prognosis.’ ”

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TOOKAD Soluble Approved for Prostate Cancer Therapy in Mexico

“A therapy invented at the Weizmann Institute of Science and clinically developed in collaboration with Steba Biotech (Luxembourg) has been approved by Cofepris, Mexico’s health authority, for the focal treatment of early-stage prostate cancer.

“The therapy involves a laser and a novel drug, TOOKAD Soluble. A successful Phase III clinical trial in Latin America (Mexico, Peru and Panama), involving 80 patients, confirmed the high rate of local cures and minimal side effects already reported in Phase II clinical trials, as evidenced by negative biopsies and maintenance of patients’ potency, continence and overall quality of life.”

Nintedanib: New Oral Angiogenesis Inhibitor in Lung Cancer

“A new oral angiogenesis inhibitor for the treatment of lung cancer could be edging closer to the market: Approval application for nintedanib (Boehringer Ingelheim) has been filed in Europe and is being prepared for the United States.

“The data for nintedanib come from the phase 3 trial known as LUME-Lung-1, recently published in the Lancet Oncology.”

Editor’s note: We previously posted a story about the potential benefits of the drug nintedanib for some patients with non-small cell lung cancer (NSCLC).


Astellas and Medivation Submit Supplemental New Drug Application for XTANDI (Enzalutamide) for Chemotherapy-Naive Advanced Prostate Cancer

“Astellas Pharma Inc. (TSE: 4503) and Medivation Inc. (NASDAQ: MDVN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI® (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.

“The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-naïve mCRPC patients. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year.”

Editor’s Note: This is a corporate press release. The takeaway for patients is that, if the application is successful, doctors will be able to start giving XTANDI (enzalutamide) to patients who have not previously had chemotherapy. The FDA has already approved the use of XTANDI for men with mCRPC who have had chemotherapy with the drug docetaxel.


Afatinib is FDA-Approved: What It Means For NSCLC Patients


On July 12, the FDA announced that it had approved the targeted therapy afatinib (Gilotrif) for the treatment of metastatic non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFR) gene.

EGFR mutations occur in about 10 to 15 percent of all NSCLC patients. The overexpression of the EGFR protein caused by the mutation leads to rapid cell division in tumors. Prior to the approval of afatinib, patients in the United States could only take erlotinib (Tarceva) to combat the EGFR mutation. The third major drug available to treat EGFR-mutated tumors, gefitinib (Iressa) has not yet been approved by the United States but is readily available in many other countries. Erlotinib has consistently outperformed gefitinib, so its lack of availability in the U.S. is no huge loss. Continue reading…


'Basket Studies' will Hold Intricate Data for Cancer Drug Approvals

“The notion of targeting specific cellular mutations to make malignancies disappear got a boost in April when the director of the US National Cancer Institute (NCI), Harold Varmus, unveiled plans for the so-called MATCH trial. Announced at the annual meeting of the American Association for Cancer Research in Washington, DC, the trial aims to match at least 1,000 individuals with a variety of cancer types with therapies that target the specific mutations found in their tumors. In a separate study described by Varmus, the NCI will also genotype 100 ‘exceptional responders’: trial participants who show noticeable improvements after treatment with cancer drugs that didn’t provide much benefit to others, in the hope of finding mutations that explain why the medicines worked.”


'Basket Studies' will Hold Intricate Data for Cancer Drug Approvals

“The notion of targeting specific cellular mutations to make malignancies disappear got a boost in April when the director of the US National Cancer Institute (NCI), Harold Varmus, unveiled plans for the so-called MATCH trial. Announced at the annual meeting of the American Association for Cancer Research in Washington, DC, the trial aims to match at least 1,000 individuals with a variety of cancer types with therapies that target the specific mutations found in their tumors. In a separate study described by Varmus, the NCI will also genotype 100 ‘exceptional responders’: trial participants who show noticeable improvements after treatment with cancer drugs that didn’t provide much benefit to others, in the hope of finding mutations that explain why the medicines worked.”


'Basket Studies' will Hold Intricate Data for Cancer Drug Approvals

“The notion of targeting specific cellular mutations to make malignancies disappear got a boost in April when the director of the US National Cancer Institute (NCI), Harold Varmus, unveiled plans for the so-called MATCH trial. Announced at the annual meeting of the American Association for Cancer Research in Washington, DC, the trial aims to match at least 1,000 individuals with a variety of cancer types with therapies that target the specific mutations found in their tumors. In a separate study described by Varmus, the NCI will also genotype 100 ‘exceptional responders’: trial participants who show noticeable improvements after treatment with cancer drugs that didn’t provide much benefit to others, in the hope of finding mutations that explain why the medicines worked.”


Watchdog approves skin cancer drugs ipilimumab and vemurafenib

Patients with an advanced form of skin cancer were given new hope today after the health watchdog recommended that two life-extending treatments should be available on the NHS.