Post image

Merck and AZ pile on more positive Lynparza data in bid to break into prostate cancer

Two months back, AstraZeneca and Merck made a strong case at the American Society of Clinical Oncology (ASCO) annual meeting that Lynparza should be the first PARP inhibitor approved to treat prostate cancer, with data showing the drug significantly delayed disease progression when added to Johnson & Johnson’s Zytiga...

Read more

First Approval for Immunotherapy for Esophageal Cancer

.

Esophageal cancer has now joined the list of tumor types that can be treated with immunotherapy, after approval of the immune checkpoint inhibitor pembrolizumab (Keytruda, Merck & Co) for this indication. This latest indication joins a growing list that also includes melanoma, lung cancer, head and neck cancer, liver, kidney and urothelial cancers, among others.

Read more
Post image
Post image

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Negative Breast Cancer (TNBC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status.

Read more

New cancer drug Keytruda will help thousands of patients

A new drug that treats cancer based on a tumour’s genetics rather than where it started in a patient’s body will become more widely available in Australia. The Therapeutic Goods Administration (TGA) has approved Keytruda, also known by the generic name pembrolizumab, to be used to treat multiple rare cancer types.

Read more
Post image
Post image

Central Drugs Standard Control Organization (CDSCO) of India to host the next 19th International Conference of Drug Regulatory Authorities (ICDRA) in 2020 .

International Conferences of Drug Regulatory Authorities (ICDRA) have been held biennially since 1980 with the aim of promoting exchange of information and collaborative approaches to issues of common concern related to regulation of medical products.

Read more

NICE shuts down AZ's Tagrisso—and backs Pfizer rival Vizimpro instead

England’s cost watchdogs won’t get behind AstraZeneca blockbuster Tagrisso in previously untreated patients with EGFR-mutated lung cancer. But in a change of events, they’re instead backing a Pfizer challenger.

Read more
Post image
Post image

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma.

Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.

Read more

The top 10 drug launches of 2019

Cancer is probably the most sought-after indication in the biopharma world, but it’s missing from 2019's class of top drug launches. Instead, treatments in immunology and rare genetic diseases have grabbed the limelight.

Read more
Post image
Post image

WARNING!! Grapefruit Juice does not mix well with some drugs, says FDA

While grapefruit juice is healthy for the body as it is rich in vitamin C, it may interfere with the action of some drugs, stated the apex drug regulatory body the US Food and Drug Administration (FDA) in its recent consumer update. In this consumer update, Shiew Mei Huang, Ph.D., of the U.S. Food and Drug Administration, stated that this food and drug interaction can be a concern and the FDA has required that some prescription and over-the-counter (OTC) drugs taken by mouth include warnings against drinking grapefruit juice or eating grapefruit while taking the drug.

Read more

Novartis wins Gilenya reprive as judge blocks generics, for now

The Boston-based Institute for Clinical and Economic Review (ICER), which has been reviewing Mayzent for months, recommended that Novartis lower the drug's price.

Read more
Post image
Post image

Pfizer's Talzenna Gets Approval in Europe for Breast Cancer.

Pfizer Inc. PFE announced that the European Commission has approved its PARP inhibitor, Talzenna (talazoparib) for BRCA-mutated advanced breast cancer in previously-treated patients. The drug is approved as monotherapy for treating locally advanced (“LA”) or metastatic breast cancer (“MBC”) patients with HER2 negative, germline breast cancer susceptibility gene (gBRCA)1/2-mutations. Patients must have received prior treatment with an anthracycline and/or a taxane in the (neo) adjuvant setting or they should be ineligible for treatment with anthracycline/ taxane.

Read more

Bristol-Myers Squibb Announces Results from CheckMate -459 Study Evaluating Opdivo (nivolumab) as a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced topline results from CheckMate -459, a randomized Phase 3 study evaluating Opdivo (nivolumab) versus sorafenib as a first-line treatment in patients with unresectable hepatocellular carcinoma (HCC). The trial did not achieve statistical significance for its primary endpoint of overall survival (OS) per the pre-specified analysis (HR=0.85 [95% CI: 0.72-1.02]; p=0.0752).

Read more
Post image
Post image

Cancer patients left in the lurch when some drugmakers stop clinical trials.

Every year, tens of thousands of people participate in clinical trials of cancer drugs, some of which lead to FDA approvals - 61 of which occurred in 2018 alone. What happens, though, to those patients after the trial has ended, and the drugs have been approved?

Read more

U.S. group says Novartis MS drug price out of line with benefit

The Boston-based Institute for Clinical and Economic Review (ICER), which has been reviewing Mayzent for months, recommended that Novartis lower the drug's price.

Read more
Post image
Post image

2019 has seen some exciting innovations in the Oncology and Hematology pipeline. Below are a few of the many newly approved products as featured on DocWire News.

FDA Expands Use of Breast Cancer Drug to Include Men, Approves Firstline Lung Cancer Combination, Approves LONSURF for Gastric Cancers, Approves First Treatment CABLIVI for Rare Blood Disease, Approves Non-Chemotherapy Combination for CLL and SLL, Approves Second-Line Liver Cancer Therapy.

Read more

FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL

On November 16, 2018, the Food and Drug Administration approved brentuximab vedotin (ADCETRIS, Seattle Genetics Inc.) in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL including sALCL.

Read more
Post image
Post image

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

On October 30, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) based on results from the KEYNOTE-407 trial

Read more

New Hope in Triple Negative Breast Cancer With Immunotherapy

MUNICH — For the first time, immunotherapy has shown a survival benefit in breast cancer. The result was seen with the anti-programmed cell death ligand 1 (PD-L1) drug atezolizumab (Tecentriq, Genentech) used with chemotherapy in triple negative breast cancer in PD-L1-positive (PD-L1+) patients. The results, from the IMpassion130 study, were presented here at the European Society for Medical Oncology (ESMO) 2018 Congress and simultaneously published in the New England Journal of Medicine.

Read more
Post image
Post image

FDA approves ivosidenib for relapsed or refractory acute myeloid leukemia

Approval was based on an open-label, single-arm, multicenter clinical trial (AG120-C-001, NCT02074839) that included 174 adult patients with relapsed or refractory AML with an IDH1 mutation confirmed using the Abbott RealTime IDH1 Assay, the FDA-approved test for selection of patients with AML for treatment with ivosidenib. Ivosidenib was given orally at a starting dose of 500 mg daily until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation. The median treatment duration was 4.1 months (range, 0.1 to 39.5 months). Twenty-one of the 174 patients (12%) received a stem cell transplant following ivosidenib treatment.

Read more

AstraZeneca receives nod to import, market cancer drug

AstraZeneca Pharma India today said it has received import and market permission from the Drug Controller General of India (DCGI) for Osimertinib (Tagrisso) tablets, prescribed as first-line treatment for certain kinds of lung cancer. AstraZeneca Pharma said approval has been granted for the product in the strengths of 40 mg and 80 mg.

Read more
Post image
Post image

First melanoma blood test to spot skin cancer early

Australian researchers have developed a blood test for melanoma in its early stages, calling it a ‘world first’ breakthrough that could save many lives. The scientists, from Edith Cowan University, said the new test could help doctors detect the skin cancer before it spreads through a person's body.

Read more

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML

On December 19, 2017, the Food and Drug Administration granted accelerated approval to bosutinib (BOSULIF, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

Read more
Post image
Post image

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer

On July 10, 2018, the Food and Drug Administration granted accelerated approval to ipilimumab (YERVOY, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Read more

FDA approves venetoclax for CLL or SLL, with or without 17 p deletion, after one prior therapy

On June 8, 2018, the Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

Read more
Post image
Post image

Bristol-Myers Squibb’s Opdivo® (nivolumab) + Low-Dose Yervoy® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.1 Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR).1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Read more

FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation

On May 4, 2018, the Food and Drug Administration approved dabrafenib (TAFINLAR®, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST®, Novartis Pharmaceuticals Corp.) in combination for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Read more
Post image
Post image

Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation

Lung cancer is one of the most common cancers in men and women, and is the leading cause of cancer-related mortality in the United States.1 According to the American Cancer Society, more than 155,000 Americans will die from lung cancer in 2017, representing approximately 25% of all cancer deaths. Non–small-cell lung cancer (NSCLC), the most common form of the disease, accounts for 80% to 85% of all lung cancer cases.

Read more

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.

The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC received nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for 4 doses followed by nivolumab monotherapy (3 mg/kg) every 2 weeks, or sunitinib 50 mg daily for 4 weeks followed by 2 weeks off every cycle.

Read more
Post image
Post image

Long-Term Gefitinib Can Be Effective in Patients With NSCLC

A subset of patients with non–small cell lung cancer (NSCLC) responded well to long-term gefitinib with a low rate of toxicity, according to a study published in Cancer.

Early clinical trials for gefitinib, an oral EGFR–tyrosine kinase inhibitor (TKI), were designed prior to discovery of the EGFR mutation. Few long-term data of the drug's safety and efficacy in patients with NSCLC were previously available.

Read more

Immunotherapy and the Risk of Myocarditis

Combinations of immune checkpoint inhibitors have the potential to cause fatal cases of fulminant myocarditis in patients with cancer, according to research recently published by Douglas B. Johnson, MD, MSCI, and colleagues at the Vanderbilt University Medical Center in Nashville, Tennessee.1 Dr Johnson is an assistant professor of medicine and directs the center's Melanoma Program.

Read more
Post image
Post image

Novartis cancer drug Zykadia gets FDA priority review

ZURICH, Feb 23 (Reuters) - The U.S. Food and Drug Administration (FDA) has granted priority review to Novartis drug Zykadia as a first-line treatment for some lung cancer patients, the Swiss drugmaker said on Thursday. The priority review covers expanded use of Zykadia (ceritinib) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive, it said.

The FDA also granted breakthrough therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain. Novartis AG had said in December that Zykadia was twice as effective as chemotherapy in slowing the progression of the rare form of lung cancer in a late-stage study.

Read more

Amgen's Kyprolis improves overall survival in blood cancer patients

Amgen Inc said on Monday new data from a late-stage trial testing Kyprolis in combination with two other drugs showed improved overall survival rate in patients with blood cancer. The company said it had filed for marketing approval with the U.S. regulator based on the results of the trial, requesting to update the Kyprolis label to include the new overall survival data.

Read more
Post image
Post image

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

“Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval demonstrates our commitment to approving advancements in treatment that give prescribers and patients different options for care.”

Read more

Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma

Since the accelerated approval of atezolizumab in May 2016, the U.S. Food and Drug Administration (FDA) has approved four additional programmed death receptor‐1 (PD‐1)/programmed death‐ligand 1 (PD‐L1) targeted immunotherapies for the treatment of patients with locally advanced or metastatic urothelial cancer. This includes the treatment of patients who have received prior platinum‐containing chemotherapy as well as patients who are not eligible for cisplatin‐containing chemotherapy. These therapies, approved within 1 year, include atezolizumab, nivolumab, durvalumab, avelumab, and pembrolizumab.

Read more
Post image
Post image

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non Small Cell Lung Cancers Harboring BRAF V600E Mutations

On June 22, 2017, the Food and Drug Administration expanded indications for dabrafenib and trametinib to include treatment of patients with metastatic non‐small cell lung cancer (NSCLC) harboring BRAF V600E mutations. Approval was based on results from an international, multicenter, multicohort, noncomparative, open‐label trial, study BRF113928, which sequentially enrolled 93 patients who had received previous systemic treatment for advanced NSCLC (Cohort B, n = 57) or were treatment‐naïve (Cohort C, n = 36).

Read more

GSK buys out Novartis in US$13 billion consumer healthcare shake-up

FRANKFURT/ZURICH: GlaxoSmithKline is buying Novartis out of their consumer healthcare joint venture for US$13 billion, taking full control of products including Sensodyne toothpaste, Panadol headache tablets, muscle gel Voltaren, and Nicotinell patches.

GSK's biggest move since Emma Walmsley became chief executive last year follows the British drugmaker's decision last week to quit the race to buy Pfizer's consumer healthcare business, endangering an auction the U.S. company hoped would bring in as much as US$20 billion.

Read more
Post image
Post image

FDA Approves Lynparza For BRCA-Positive Breast Cancer

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the registrational phase 2 KEYNOTE-224 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, who were previously treated with systemic therapy (sorafenib). Results showed an overall response rate (ORR) of 16.3 percent (95% CI, 9.8-24.9) (n=17/104) with KEYTRUDA as monotherapy. Data also include six-month overall survival (OS) and progression-free survival (PFS) rates. The findings will be presented at the 2018 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium in San Francisco in an oral presentation on Friday, Jan. 19, from 1:10-1:15 p.m. PT (Location: Level 3 – Room 3014) (Abstract #209).

Read more

FDA Approves Lynparza For BRCA-Positive Breast Cancer

Lynparza (olaparib), a PARP inhibitor, was granted approval by the Food and Drug Administration (FDA) for the treatment of patients with BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy. Also, patients who have HR-positive disease should have prior endocrine therapy or they would not be considered appropriate for such treatment.

This approval is based on results from the phase 3 OlympiAD trial, which showed that Lynparza reduced the risk of disease progression or death by 42 percent and improved progression-free survival (PFS) by 2.8 months versus standard chemotherapy in previously treated patients with BRCA-positive, HER2-negative breast cancer.

Treatment selection for Lynparza is based on the BRACAnalysis CDx genetic test, which today had its FDA approval expanded to include the detection of BRCA mutations in patients with breast cancer.

Read more
Post image