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FDA Updates: Genentech Withdraws Tecentriq Indication; New Approvals for Xarelto, Tibsovo


Tecentriq loses indication, Xarelto is approved for reduce risks of cardiovascular events, Tibsovo is approved for rare cancer, Skytrofa is a new, once-weekly growth hormone, and supplemental application is filed Orencia graft-versus-host disease.

Genentech withdraws Tecentriq approval for metastatic breast cancer.

Genentech has withdrawn the U.S. accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Celgene’s Abraxane, albumin-bound paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.

Tecentriq was granted accelerated approval by the FDA for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. Continued approval was contingent upon the results of IMpassion131, which was a postmarketing commitment required by the FDA. This study did not meet its primary endpoint of progression-free survival for first-line treatment of people with mTNBC.

Although the FDA Oncology Drugs Advisory Committee voted 7 to 2 on April 27, 2021, in favor of maintaining the accelerated approval of Tecentriq, Genentech officials made the decision to withdraw the indication because of changes in the treatment landscape, they said in a statement.

One of those changes was the accelerated approval of Merck’s Keytruda (pembrolizumab) in November 2020 for the same indication.

FDA approves expanded indication for Xarelto.

The FDA has approved an expanded peripheral artery disease indication for the Janssen’s Xarelto (rivaroxaban) to include patients following recent lower-extremity revascularization.

With this approval, Xarelto is the first therapy indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease and major thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with peripheral artery disease.

Peripheral artery disease is a chronic circulatory condition that causes blood vessels to narrow, reducing blood flow to the limbs, most often the legs. It is a disease which often goes undiagnosed and undertreated. In fact, an estimated 20 million Americans are living with the disease, but only 8.5 million are currently diagnosed. It is the leading cause of amputations in the United States.

Xarelto now has nine indications.

FDA approves Tibsovo for rare, aggressive cancer.

The FDA has approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) to treat adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1. TIBSOVO is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts within and outside of the liver.

An estimated 8,000 people in the United States are diagnosed with cholangiocarcinoma each year. But the actual number of these cases is likely higher, as this cancer can be hard to diagnose, and may be misclassified as other types of cancer.

At the same time, the FDA approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for Tibsovo.

The Oncomine Dx Target Test is a next-generation sequencing (NGS) based test that delivers reproducible results in the IDH1 gene clinically associated with CCA. The FDA first approved the test as a CDx in 2017, and it is now approved for four targeted therapies for non-small cell lung cancer and one targeted therapy for CCA in the United States. The test is currently approved and reimbursed by government and commercial insurers in more than 15 countries.

FDA approves long-acting growth hormone.

The FDA has approved Skytrofa (lonapegsomatropin-tcgd), developed by Ascendis Pharma to treat children one year and older who have growth failure. This is the first FDA approved product that delivers somatropin by sustained release over one week.

In growth hormone deficiency, the pituitary gland does not produce enough growth hormone, which is important not only for height but also for a child’s overall endocrine health and development.

The approval is based on results from the phase 3 heiGHt trial, a 52-week, global trial that compared the once-weekly therapy with daily somatropin (Genotropin) in 161 treatment-naïve children. No serious adverse events or discontinuations related to the therapy were reported.

The once-weekly therapy uses TransCon technology, which was developed by Ascendis. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. Because the drug is unmodified, its original mode of action is expected to be maintained, according to Ascendis officials.

FDA approves drug for itching associated with kidney disease.

The FDA has approved Korsuva (difelikefalin) for the treatment of patients with moderate-to-severe pruritis, or itchy skin, associated with chronic kidney disease in adults undergoing hemodialysis. Korsurva, developed by Cara Therapeutics and Vifor Pharma, is a first-in-class kappa opioid receptor agonist that targets the body’s peripheral nervous system.

The approval is based on positive data from two pivotal phase 3 trials, as well as supportive data from an additional 32 clinical studies. Korsuva was found to be generally well tolerated.

Vifor Pharma expects to begin to market the therapy in the first quarter of 2022.

BMS files supplemental application for Orencia.

The FDA has accepted Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate-to-severe acute graft-versus-host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT). The FDA granted the application priority review and assigned a PDUFA goal date of December 23, 2021.

If approved, Orencia would become the first therapy for the prevention of aGvHD.

The sBLA submitted to the FDA is based on results from the phase 2 ABA2 trial and a registry trial based on real-world evidence. The ABA2 trial assessed the impact of Orencia on the prevention of severe aGvHD, when added to a standard GvHD prophylactic regimen.

Orencia is approved to treat adults with rheumatoid arthritis and psoriatic arthritis, as well as children with polyarticular juvenile idiopathic arthritis.

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