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Rolvedon™ (eflapegrastim-xnst) injection has been approved to decrease the incidence of chemotherapy-induced febrile neutropenia in adult patients.

• Manufactured by Spectrum Pharmaceuticals, Inc., Rolvedon™ injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
• Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim or filgrastim Reactions may include anaphylaxis.
• It is expected to be available in fourth quarter 2022.

Daxxify™ (daxibotulinumtoxin-A-lanm) has been approved as an injection to temporarily improve the look of moderate to severe frown lines (glabellar lines) in adults.

• Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced approval of Daxxify by the FDA.
• Daxxify is the first and only neuromodulator stabilized with Peptide Exchange Technology™ (PXT) and is free of both human serum albumin and animal-based It is due to be available sometime in 2023.
• Daxxify contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).
• Daxxify is not recommended for use in children or pregnant women.

Sotyktu™ (deucravacitinib) has been approved for use as an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults.

• Manufactured by Bristol-Myers Squibb, Sotyktu is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatment for moderate-to-severe plaque psoriasis in nearly 10 years.
• Sotyktu is not recommended for use in combination with other potent It is currently available at wholesale acquisition cost (WAC) of $6,164.78 for a 30-day supply.

Stimufend® (pegfilgrastim), a biosimilar of Amgen’s Neulasta®, has been approved for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with significant incidence of febrile neutropenia.

• Fresenius Kabi, a global health care company, announced FDA approval of its pegfilgrastim biosimilar, Stimufend, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• The company expects to launch the product in a prefilled syringe early next year and in an on- body injector.

The U.S. FDA approved Orkambi^® (lumacaftor/ivacaftor) for children with cystic fibrosis ages 1-2 years who have two F508del mutations.

• Manufactured by Vertex Pharmaceuticals Incorporated, Orkambi was previously approved by the FDA for use in people with CF ages 2 years and older with two copies of the 508del mutation.

• This is the third expansion of Orkambi to younger age groups since Orkambi was first approved in 2015 for people with CF ages 12 years and older with two copies of the F508del The drug is one of four medicines approved to treat the faulty CTFR protein, the underlying cause of CF.

The Food and Drug Administration has approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC).

• Imfinzi was originally approved by the FDA, May 1, 2017, for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Xenpozyme™ (olipudase alfa-rpcp) has been approved for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients.

• Xenpozyme, manufactured by Sanofi, is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease.
• ASMD represents a spectrum of disease, with two types that may represent opposite ends of a continuum referred to as ASMD type A and ASMD type ASMD type A/B is an intermediate form that includes varying degrees of central nervous system (CNS) involvement.
• Xenpozyme is administered intravenously every two weeks, and its administration requires a dose escalation phase followed by a maintenance phase.
• It is expected that Xenpozyme will be available in the S. in the coming weeks. The U.S. list price, or wholesale acquisition cost, of Xenpozyme is $7,142.00 per vial.

Konvomep™ (omeprazole and sodium bicarbonate for oral suspension) has been approved for gastric ulcer and reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients.

• Azurity Pharmaceuticals, Inc. has received FDA approval for the use of Konvomep, an oral liquid formulation of the FDA-approved proton pump inhibitor omeprazole and sodium bicarbonate combination
• It is expected that Konvomep™ will become commercially available in pharmacies nationwide in Q1 2023.

For full prescribing and additional information, please go to www.konvomep.com

The Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

• Efficacy was established based on complete response (CR) rates per the response criteria relevant to the morphologic disease type.
• The recommended pemigatinib dose is 13.5 mg orally once daily on a continuous basis until disease progression or unacceptable toxicity.

The FDA approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.

• The recommended dosage of Imbruvica for patients 12 years of age and older with cGVHD is 420 mg orally once daily, and for patients 1 to less than 12 years of age with cGVHD is 240 mg/m2 orally once daily (up to a dose of 420 mg), until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity.