Month: February 2025

…………………. catching up on recent FDA approvals

The FDA recently approved a new infused therapy, Bizengri (zenocutuzumab-zbco) from Merus N.V., indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy.

Bizengri is a bispecific antibody that binds to the extracellular domains of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3. The therapy is the first and only treatment approved for these indications. Approval for these indications may be contingent upon verification of clinical benefit in a confirmatory trial(s).

Bizengri was approved with a Black Box warning for Embryo-Fetal Toxicity.  

The company did not announce the price for Bizengri.

Similarly, the company did not announce plans for distribution.

CLICK HERE to access prescribing information

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Merus Announces FDA Approval of Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC) 

Click Here to read the full company press release

The FDA recently approved a biosimilar, Yesintek (Ustekinumab-kfce) from Biocon Biologics Ltd, as a biosimilar to the reference product, Stelara (Ustekinumab).  

This approval is the newest biosimilar approval for a Stelara competitor. 

The currently approved biosimilars include — Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce).

Yesintek is indicated for—–

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.
• Pediatric patients 6 years of age and older with:
• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
• active psoriatic arthritis.

Prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.

CLICK HERE for prescribing information

The company plans its product launch in the United States later in February following a settlement with J&J. Distribution details were not announced.  

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FDA Approves Biocon Biologics Ustekinumab Biosimilar, Yesintek

Click Here to read the full article

……….. catching upon FDA approvals

The FDA recently approved a new ORAL specialty therapy, Revuforj (revumenib) from Syndax Pharmaceuticals, for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.  

Revuforj is the first and only menin inhibitor approved for the condition.  

The therapy was granted Orphan Drug status.

The company priced Revuforj at $39,500 per month, or $474,000 annually.

Revuforj was approved with a Black Box warning for differentiation syndrome, a potentially fatal condition in which leukemia cells rapidly release cytokines. 

CLICK HERE to access prescribing information 

Syndax announced that Revuforj launched through a network of specialty distributors and specialty pharmacies and full availability all doses by Q2-2025. An oral solution will be available through an expanded access program to allow for dosing of patients who weigh less than 40 kg.

As of this date only Onco360 has confirmed its selection to be an authorized dispensing pharmacy for Revuforj.

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Syndax Announces FDA Approval of Revuforj (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation

Click here to access the full company press release

………… catching up on FDA approvals

The FDA recently approved a new infused therapy, Aucatzyl (obecabtagene autoleucel) from Autolus Inc., indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Aucatzyl is a CD19-directed genetically modified autologous T cell immunotherapy.

Acute lymphoblastic leukemia is a cancer in which B-cell lymphoblasts are found in the bone marrow and blood. ALL accounts for less than 1% of all cancers in the United States. The American Cancer Society estimates that in 2024 there will be about 6,550 new cases of ALL and about 1,330 deaths. Survival rates remain very poor in adult patients with r/r ALL, with median overall survival of eight months.

Aucatzyl was approved with a Black Box warning, however, the FDA did not impose a REMS program which is uncommon.

The company confirmed that the annual wholesale acquisition cost for Aucatzyl is $525,000. It is priced in the same general price bracket as two competing products, Kymriah and Tecartus.  

The company did not announce details on its plans for distribution.

CLICK HERE to access prescribing information

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FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia  Aucatzyl

CLICK HERE to read the full FDA press release