…………………. 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

The NHIA recently released a comprehensive list of therapies that have been routinely dispensed by home infusion providers. This comprehensive grouping, especially by therapeutic category and related prescribing practices, is both insightful and practical.   

Specialty pharmacies that distribute key therapies may benefit from a reliable marketplace point of reference. In a broader sense, the marketplace can benefit from both seeing the large (and growing) array of therapies that can be administered in a lower cost ‘site of service’ outside the hospital. This distinction also goes to the heart of the ‘site of service’ appropriateness debate currently hotly contested around oncology therapies.

CLICK HERE to access the NHIA Home Infusion Drug List

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NHIA Home Infusion Drug List

The National Home Infusion Association (NHIA) Home Infusion Drug List contains the names and therapeutic categories of drugs that were compiled from medication dispensing reports submitted by home infusion providers and reflects current prescribing practices in the United States. The National Home Infusion Association (NHIA) Home Infusion Drug List may serve as a reference for decisions related to the site of care for administering drugs requiring intravenous or subcutaneous infusion.

This reference only lists prescribed drugs and does not endorse home infusion for patients who do not meet the criteria for safe administration in the home or alternate site of care. NHIA members and other practitioners using the list should exercise independent judgment and provide the patient with a choice in their site of care decision based on their individual situation. Additionally, not all home infusion providers offer every medication included on the list. Providers may specialize and only offer certain therapies.

The NHIA Home Infusion Drug List was developed collaboratively by NHIA staff and member volunteers comprised of pharmacists, nurses, and other professionals with extensive experience and expertise in the field of home infusion. The NHIA Quality and Standards Committee reviewed the list by category and drugs included for accuracy. The category selected for each medication was based on the chemical form of the active ingredient, the clinical use for a particular diagnosis, and/or the corresponding per diem where applicable. The committee members made recommendations that were incorporated prior to finalizing and approving the list and communication materials.

The FDA recently approved a new infused therapy, Vyloy (zolbetuximab-clzb) – in combination with fluoropyrimidine and platinum-containing chemotherapy – from Astellas Pharma Inc., for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

Vyloy is the first and only CLDN18.2-targeted therapy approved in the U.S. After a starting dose of 800 mg/m2 Vyloy is infused 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks.

Vyloy has been priced at $1600 per 100mg vial.

Onco360 has been selected as a national pharmacy partner by Astellas for Vyloy.  

CLICK HERE to access prescribing information

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Astellas’ VYLOY (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive

CLICK HERE to read the full press release

So, how much do you know about bispecific therapy?

Can you even offer a passing definition?

Well, read on dear reader….. and learn enough to impress your colleagues!

Why is knowing about bispecific therapies even remotely important?

Although they have been around for more than a decade, bispecifics are back and making big news in disease management. Currently, there are over 100 bispecifics in clinical development. AstraZeneca, BioNTech and Summit Therapeutics are just a few pharma with pipeline products. KOLs believe that bispecifics are the next new thing in immunotherapy with promise to even surpass the pioneering performance of monoclonal antibody therapy Keytruda.

Here’s the definition that you need to know to sound well informed……

Bispecific antibodies are engineered to bind to cancer cells and healthy immune system cells (T-cells) at the same time, activating the healthy immune system cells to recognize and destroy cancerous cells. 

The article below does a good job of filling in more detail to assuage your insatiable curiosity.

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With Myriad Recent Approvals in Cancer, The Era of Bispecifics Is Here

 As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.

CLICK HERE to read the full article

This new year should be verrrrry interesting…… especially with respect to the FDA and a host of changes that are likely to be implemented in the agency. One area that is likely to come under the microscope is the FDA Accelerated Approval Pathway.

In short, the pathway is a shortcut to approval of a new therapy. On its surface, the rationale behind accelerated approval makes a lot of sense. Why delay making a therapy with great ‘promise’ available, especially a life-saving therapy, to reach desperate patients as soon as possible.

As noted in the article below, the pathway was implemented in 1992 in response to the HIV/AIDS epidemic, accelerated approval enables drugs to be approved based on a surrogate endpoint that is reasonably likely to predict clinical benefit. These FDA approvals allow pharmaceutical companies to begin selling these drugs on the condition that they conduct confirmatory trials. Since its inception, the pathway has helped bring nearly 300 new drugs to the market, many for conditions with high unmet need.

Well, as with most things, perfection in pharmaceuticals is also a rare commodity. Fortunately, the number of therapies that originally received accelerated approval, only to be later yanked off the market due to ‘unforeseen consequences’ (sometimes fatal), have been relatively few. None the less, only a few ‘oops’ beg the question…. Are even a few deaths or other serious adverse events worth the risks?

The article below is a good read that adds perspective to the question of accelerated approvals and their future in the FDA approval process.

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5 Accelerated Approvals Gone Wrong

CLICK HERE to read the full article

The year 2024 was a very busy year for specialty pharmacy. So many SP therapies were approved by the FDA that we are still catching up on all the announcements.  

What we did NOT see in 2024 was much activity on the business front….. especially SP acquisitions, major expansions, etc. However, days ago, perhaps the biggest story of the year hit the ether….. Walgreens (WAGS) is facing a serious reversal of fortunes to the tune of $billions$ of dollars. The numbers are jaw dropping….. about 10 years ago Walgreens’ market cap was more than $100 billion. They ended the year with a valuation of only $8 billion.

We’ve watched with curiosity the remaking of WAGS over the past decade and much of that transformation came with $billion$ dollar price tags. That spending spree has cost WAGS dearly leading to discussions with at least one private equity firm to form a consortium to take WAGS private.  

Current WAGS management has been aggressively cleaning shop including closing underperforming retail stores and whole divisions such as VillageMD. As is typical in these deals, the investors will continue to slash operating costs and sell off assets that are not accretive or simply don’t ‘fit’ in the new company vision.  

What might WAGS look like in the wake of a going private?

Only the profitable retail locations will survive.

WAGS will actively partner with third parties to hedge financial exposure.

WAGS will continue to pursue deals with hospitals and health systems, one of the strategies that seem to have been successful over recent years.

WAGS will continue to compete in specialty pharmacy.

Succeeding in specialty pharmacy may not be as easy as it might look.  

The acquisition of Shields Health was integral to structure deals with hospitals and health systems around specialty pharmacy. But, once that intellectual property has been transferred, will clients feel the need for those contracts to be renewed?  

There are three articles worth reading to get a better lay of the financial landscape that WAGS needs to traverse in coming days. 

CLICK HERE to read the Forbes article  Walgreens in talks to go private

CLICK HERE to read the Axios article    Sycamore Walgreens take private partner

CLICK HERE to read the Axios article    Walgreens Rocky Road

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are seven LD deals that have been publicly confirmed subsequent to their approvals.

Orsini to Distribute Furoscix  

Orsini has been selected by SC Pharmaceuticals to distribute Furoscix (furosemide injection), an Infused diuretic for Congestive Heart Failure indicated for the treatment of congestion due to fluid overload in adults. Furoscix is available as a subcutaneous, single-use therapy that can be administered at home by patients and caregivers.

Orsini to Distribute Sajazir

Orsini has been chosen by Cycle Pharmaceuticals to distribute Sajazir (icatibant) Injection, a subcutaneous treatment for acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. 

CareMed to Distribute Leqembi

CareMed, a BrightSpring Health Services company, has been selected by Eisai to be the national specialty pharmacy provider for Leqembi, indicated for Alzheimer’s disease.

Onco360 to Distribute Leqembi

Onco360 has been selected as a pharmacy partner by Genentech to distribute Itovebi (inavolisib) which is indicated, in combination with palbociclib and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Onco360 to Distribute Revuforj

Onco360 has been selected as a national pharmacy partner by Syndax Pharmaceuticals for Revuforj (revumenib). Revuforj is the first and only menin inhibitor approved for the treatment of relapsed or refractory (R/R) acute leukemias with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.

Orsini to Distribute Casgevy

Orsini has been selected by Vertex Pharmaceuticals Inc to dispense gene-editing therapy Casgevy (exagamglogene autotemcel). Casgevy is a CRISPR/Cas9 gene-edited cell therapy indicated for the treatment of patients aged 12 years and older with (1) sickle cell disease (SCD) with recurrent vaso-occlusive crises or (2) transfusion-dependent β-thalassemia (TDT).

InspiroGene by McKesson to Distribute Casgevy

InspiroGene* has been selected by Vertex Pharmaceuticals Incorporated to expand commercial distribution options for Casgevy (exagamglogene autotemcel). Casgevy is a CRISPR/Cas9 gene-edited cell therapy indicated for the treatment of patients aged 12 years and older with (1) sickle cell disease (SCD) with recurrent vaso-occlusive crises or (2) transfusion-dependent β-thalassemia (TDT).

_*  InspiroGene is a dedicated business unit of McKesson that specifically focuses on the commercialization of cell and gene therapies (CGTs) and operates in conjunction with business units Biologics by McKesson Specialty Pharmacy and specialty distributor McKesson Plasma & Biologics.