US FDA Approved Medicines

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.

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.

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.

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.

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.

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.

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.

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).

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?

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.

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.

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.

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

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

“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.”

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.

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).

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.

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).

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.