I am pleased to announce that the US Food and Drug Administration (FDA) has approved EXKIVITY™ (mobocertinib), the first oral therapy to target epidermal growth factor receptor (EGFR) exon 20 insertion mutations in metastatic non-small cell lung cancer (NSCLC).1 EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).1 EGFR exon 20 insertion-positive NSCLC is a rare subtype of NSCLC.2 EXKIVITY is a tyrosine kinase inhibitor developed to inhibit EGFR exon 20 insertion mutations.1 The most common (>20%) adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased amylase, increased lipase, decreased potassium, decreased hemoglobin, increased creatinine, and decreased magnesium.1

IMPORTANT SAFETY INFORMATION       WARNING: QTc PROLONGATION and TORSADES DE POINTES See full prescribing information for complete boxed warning. • EXKIVITY can cause life-threatening heart rate–corrected QT (QTc) prolongation, including Torsades de Pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation [see Warnings and Precautions].   • Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc.   • Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of QTc prolongation.

Please see additional Important Safety Information below. EXKIVITY is now available in the following strength and package size1: Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].1 EXKIVITY is available by prescription through Biologics and Onco360 Specialty Pharmacies. Practices may also arrange for in-office dispensing via ASD Healthcare, Cardinal, and Oncology Supply. For information about patient access support and financial assistance that your patients may qualify for, call Takeda Oncology Here2Assist™ at 1-844-817-6468, Option 2. Let’s Talk. We’re available Monday-Friday, 8am–8pm ET, or visit us at www.Here2Assist.com/hcp to learn more.

IMPORTANT SAFETY INFORMATION (CONT’D) WARNINGS AND PRECAUTIONS QTc Prolongation and Torsades de Pointes EXKIVITY can cause life-threatening heart rate–corrected QT (QTc) prolongation and Torsades de Pointes, which can be fatal. In the 250-patient subset of the pooled EXKIVITY safety population who had scheduled and unscheduled electrocardiograms (ECGs), 1.2% of patients had a QTc interval >500 msec and 11% of patients had a change-from-baseline QTc interval >60 msec. Grade 4 Torsades de Pointes occurred in 1 patient (0.4%). Clinical trials of EXKIVITY did not enroll patients with a baseline QTc greater than 470 msec. Assess QTc and electrolytes at baseline and correct abnormalities in sodium, potassium, calcium, and magnesium prior to initiating EXKIVITY. Monitor QTc and electrolytes periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation, such as patients with congenital long QT syndrome, heart disease, or electrolyte abnormalities. Avoid use of concomitant drugs which are known to prolong the QTc interval. Avoid concomitant use of strong or moderate CYP3A inhibitors with EXKIVITY, which may further prolong the QTc. Withhold, reduce the dose, or permanently discontinue EXKIVITY based on the severity of the QTc prolongation. Interstitial Lung Disease (ILD)/Pneumonitis EXKIVITY can cause ILD/pneumonitis, which can be fatal. In the pooled EXKIVITY safety population, ILD/pneumonitis occurred in 4.3% of patients, including Grade 3 events in 0.8% of patients and fatal events in 1.2% of patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold EXKIVITY in patients with suspected ILD/pneumonitis, and permanently discontinue EXKIVITY if ILD/pneumonitis is confirmed. Cardiac Toxicity EXKIVITY can cause cardiac toxicity (including decreased ejection fraction, cardiomyopathy, and congestive cardiac failure) resulting in cardiac failure. In the pooled EXKIVITY safety population, cardiac failure occurred in 2.7% of patients, including Grade 3 reactions in 1.2% of patients, Grade 4 reactions in 0.4% of patients, and one (0.4%) fatal case of cardiac failure. EXKIVITY can cause QTc prolongation resulting in Torsades de Pointes. Atrial fibrillation (1.6%), ventricular tachycardia (0.4%), first-degree atrioventricular block (0.4%), second-degree atrioventricular block (0.4%), left bundle branch block (0.4%), supraventricular extrasystoles (0.4%), and ventricular extrasystoles (0.4%) also occurred in patients receiving EXKIVITY. Monitor cardiac function, including assessment of left ventricular ejection fraction at baseline and during treatment. Permanently discontinue EXKIVITY for symptomatic cardiac failure. Diarrhea EXKIVITY can cause diarrhea, which can be severe. In the pooled EXKIVITY safety population, diarrhea occurred in 93% of patients, including Grade 3 events in 20% of patients and Grade 4 events in 0.4% of patients. The median time to first onset of diarrhea was 5 days, but diarrhea has occurred within 24 hours after administration of EXKIVITY. In the 48% of patients whose diarrhea resolved, the median time to resolution was 3 days. Prolonged diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment. Treat diarrhea promptly. Advise patients to start an antidiarrheal agent (eg, loperamide) at first evidence of increased frequency of bowel movement or first episode of unformed, loose stool and to increase fluid intake during diarrhea episodes. Monitor electrolytes and instruct patients to increase fluid and electrolyte intake as needed. Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, EXKIVITY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with EXKIVITY and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with EXKIVITY and for 1 week after the last dose of EXKIVITY. ADVERSE REACTIONS The most common (>20%) adverse reactions are diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The most common (>2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased amylase, increased lipase, decreased potassium, decreased hemoglobin, increased creatinine, and decreased magnesium. DRUG INTERACTIONS CYP3A Inhibitors Coadministration of EXKIVITY with strong or moderate CYP3A inhibitors increased mobocertinib plasma concentrations, which may increase the risk of adverse reactions, including QTc interval prolongation. Avoid concomitant use of strong or moderate CYP3A inhibitors with EXKIVITY. If concomitant use of moderate CYP3A inhibitors cannot be avoided, reduce the EXKIVITY dose and monitor the QTc interval more frequently with ECGs. CYP3A Inducers Coadministration of EXKIVITY with strong or moderate CYP3A inducers decreases mobocertinib plasma concentrations, which may reduce EXKIVITY antitumor activity. Avoid concomitant use of strong or moderate CYP3A inducers with EXKIVITY. CYP3A Substrates Coadministration of EXKIVITY with CYP3A substrates may decrease plasma concentrations of CYP3A substrates, which may reduce the efficacy of these substrates. Avoid concomitant use of hormonal contraceptives with EXKIVITY. Avoid concomitant use of EXKIVITY with other CYP3A substrates where minimal concentration changes may lead to serious therapeutic failures. If concomitant use is unavoidable, increase the CYP3A substrate dosage in accordance with the approved product Prescribing Information. Prolonged QTc Interval EXKIVITY can cause QTc interval prolongation. Coadministration of EXKIVITY with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation. Avoid concomitant use of other medications known to prolong the QTc interval with EXKIVITY. If concomitant use is unavoidable, monitor the QTc interval more frequently with ECGs. USE IN SPECIFIC POPULATIONS Pregnancy Based on findings from animal studies and its mechanism of action, EXKIVITY can cause fetal harm when administered to a pregnant woman. There are no clinical data available on the use of EXKIVITY in pregnant women. Females and Males of Reproductive Potential Verify pregnancy status in females of reproductive potential prior to initiating EXKIVITY. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with EXKIVITY and for at least 1 week following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with EXKIVITY and for at least 1 week following the final dose. Lactation There are no data on the presence of mobocertinib or its metabolites in human milk or their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with EXKIVITY and for 1 week after the last dose. To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Boxed Warning. To learn more about EXKIVITY, please visit EXKIVITYhcp.com. You may always reach me by phone or email at the contact information provided below.

Posted 9/24/2021

Please visit the link below for the Prescribing Information:

Brukinsa MZL HCP 2-page Overview 9-15-21

Posted 9/5/2021

Please visit the link below for the Prescribing Information:

BRUKINSA USPI-WM-FINAL-31AUG2021

Posted 9/5/2021

We’re pleased to announce that SARCLISA^® (isatuximab-irfc) is now approved, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

Please see our press release or contact me for more information.

 INDICATION

SARCLISA (isatuximab-irfc) is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.

SARCLISA is indicated, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SARCLISA is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

Serious infusion-related reactions (IRRs), including life-threatening anaphylactic reactions, have occurred with SARCLISA treatment. Severe signs and symptoms include cardiac arrest, hypertension, hypotension, bronchospasm, dyspnea, angioedema, and swelling.

Based on ICARIA-MM, IRRs occurred in 38% of patients treated with SARCLISA, pomalidomide, and dexamethasone (Isa-Pd). All IRRs started during the first SARCLISA infusion and resolved on the same day in 98% of the cases.

In IKEMA, infusion-related reactions occurred in 46% of patients treated with SARCLISA, carfilzomib, and dexamethasone (Isa-Kd). In the Isa-Kd arm, the infusion-related reactions occurred on the infusion day in 99% of episodes. In patients treated with Isa-Kd, 95% of those experiencing an infusion-related reaction experienced it during the first cycle of treatment. All infusion-related reactions resolved: within the same day in 74% of episodes, and the day after in 24% of episodes.

The most common symptoms (≥5%) of an infusion-related reaction in ICARIA-MM and IKEMA (N=329) included dyspnea, cough, nasal congestion, and nausea. Anaphylactic reactions occurred in less than 1% of patients. To decrease the risk and severity of IRRs, premedicate patients prior to SARCLISA infusion with acetaminophen, H₂ antagonists, diphenhydramine or equivalent, and dexamethasone.

Monitor vital signs frequently during the entire SARCLISA infusion. For patients with grade ≥2 reactions, interrupt SARCLISA infusion and provide appropriate medical management. For patients with grade 2 or grade 3 reactions, if symptoms improve to grade ≤1, restart SARCLISA infusion at half of the initial infusion rate, with supportive care as needed, and closely monitor patients. If symptoms do not recur after 30 minutes, the infusion rate may be increased to the initial rate, and then increased incrementally. In case symptoms do not improve to grade ≤1 after interruption of SARCLISA infusion, persist or worsen despite appropriate medications, or require hospitalization, permanently discontinue SARCLISA and institute appropriate management. Permanently discontinue SARCLISA if an anaphylactic reaction or life-threatening (grade 4) IRR occurs and institute appropriate management.

Neutropenia

SARCLISA may cause neutropenia.

In patients treated with Isa-Pd, neutropenia occurred in 96% of patients and grade 3-4 neutropenia occurred in 85% of patients. Neutropenic complications occurred in 30% of patients, including febrile neutropenia (12%) and neutropenic infections (25%), defined as infection with concurrent grade ≥3 neutropenia. The most frequent neutropenic infections included infections of the upper respiratory tract (10%), lower respiratory tract (9%), and urinary tract (3%).

In patients treated with Isa-Kd, neutropenia occurred in 55% of patients, with grade 3-4 neutropenia in 19% of patients (grade 3 in 18% and grade 4 in 1.7%). Neutropenic complications occurred in 2.8% of patients, including febrile neutropenia (1.1%) and neutropenic infections (1.7%).

Monitor complete blood cell counts periodically during treatment. Consider the use of antibiotics and antiviral prophylaxis during treatment. Monitor patients with neutropenia for signs of infection. In case of grade 4 neutropenia, delay SARCLISA dose until neutrophil count recovery to at least 1.0 x 10⁹/L, and provide supportive care with growth factors, according to institutional guidelines. No dose reductions of SARCLISA are recommended.

Second Primary Malignancies

The incidence of second primary malignancies is increased in patients treated with SARCLISA-containing regimens. The overall incidence of second primary malignancies in all the SARCLISA-exposed patients was 3.6%.

In ICARIA-MM, second primary malignancies occurred in 3.9% of patients in the Isa-Pd arm and in 0.7% of patients in the Pd arm.

 In IKEMA, second primary malignancies occurred in 7% of patients in the Isa-Kd arm and in 4.9% of patients in the Kd arm.

The most common (≥1%) second primary malignancies in ICARIA-MM and IKEMA (N=329) included skin cancers (4% with SARCLISA-containing regimens and 1.5% with comparative regimens) and solid tumors other than skin cancer (1.8% with SARCLISA-containing regimens and 1.5% with comparative regimens). All patients with skin cancer continued treatment after resection of the skin cancer.

Monitor patients for the development of second primary malignancies.

Laboratory Test Interference

Interference with Serological Testing (Indirect Antiglobulin Test)

 SARCLISA binds to CD38 on red blood cells (RBCs) and may result in a false-positive indirect antiglobulin test (indirect Coombs test). The indirect antiglobulin test was positive during Isa-Pd treatment in 68% of the tested patients, and during Isa-Kd treatment in 63% of patients. In patients with a positive indirect antiglobulin test, blood transfusions were administered without evidence of hemolysis. ABO/RhD typing was not affected by SARCLISA treatment.

Before the first SARCLISA infusion, conduct blood type and screen tests on SARCLISA-treated patients. Consider phenotyping prior to starting SARCLISA treatment. If treatment with SARCLISA has already started, inform the blood bank that the patient is receiving SARCLISA and that SARCLISA interference with blood compatibility testing can be resolved using dithiothreitol-treated RBCs. If an emergency transfusion is required, non–cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices.

Interference with Serum Protein Electrophoresis and Immunofixation Tests

 SARCLISA is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the accuracy of the determination of complete response in some patients with IgG kappa myeloma protein.

Embryo-Fetal Toxicity

Based on the mechanism of action, SARCLISA can cause fetal harm when administered to a pregnant woman. SARCLISA may cause fetal immune cell depletion and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use an effective method of contraception during treatment with SARCLISA and for at least 5 months after the last dose. The combination of SARCLISA with pomalidomide is contraindicated in pregnant women because pomalidomide may cause birth defects and death of the unborn child. Refer to the pomalidomide prescribing information on use during pregnancy.

 ADVERSE REACTIONS

In combination with pomalidomide and dexamethasone: The most common adverse reactions (≥20%) were upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea. The most common hematology laboratory abnormalities (≥80%) were decreased hemoglobin, decreased neutrophils, decreased lymphocytes, and decreased platelets.

In combination with carfilzomib and dexamethasone: The most common adverse reactions (≥20%) were upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. The most common hematology laboratory abnormalities (≥80%) were decreased hemoglobin, decreased lymphocytes, and decreased platelets.

Serious adverse reactions occurred in 62% of patients receiving Isa-Pd. Serious adverse reactions in >5% of patients who received Isa-Pd included pneumonia (26%), upper respiratory tract infections (7%), and febrile neutropenia (7%). Fatal adverse reactions occurred in 11% of patients (those that occurred in more than 1% of patients were pneumonia and other infections [3%]).

Serious adverse reactions occurred in 59% of patients receiving Isa-Kd. The most frequent serious adverse reactions in >5% of patients who received Isa-Kd were pneumonia (25%) and upper respiratory tract infections (9%). Adverse reactions with a fatal outcome during treatment were reported in 3.4% of patients in the Isa-Kd group (those occurring in more than 1% of patients were pneumonia occurring in 1.7% and cardiac failure in 1.1% of patients).

 USE IN SPECIAL POPULATIONS

Because of the potential for serious adverse reactions in the breastfed child from isatuximab-irfc administered in combination with Pd, advise lactating women not to breastfeed during treatment with SARCLISA.

Please click here for full Prescribing Information.

Colorado prescribers may click here for Wholesale Acquisition Cost Price Disclosure Information.

Posted 4/5/2021

On behalf of Pfizer, it is our pleasure to inform you that on November 30th, 2020, the U.S. Food and Drug Administration (FDA) approved the 150 mg single-dose vial of TRAZIMERA^® (trastuzumab-qyyp). TRAZIMERA (trastuzumab-qyyp) is a biosimilar to Herceptin^®Ϯ (trastuzumab). As of March 10^th, 2021 this new presentation is now available for commercial sale.

 

Please review the TRAZIMERA Full Prescribing Information, including BOXED WARNINGS, for detailed information.

 

The product information, including new NDC, is listed in the table below.

 

TRAZIMERA Product Information

	NEW	EXISTING
Type	Single-dose vial	Multiple-dose vial
Strength	150 mg of TRAZIMERA as a white lyophilized powder in a single-dose vial	420 mg of TRAZIMERA as a white lyophilized powder in a multiple-dose vial
Package size	1 vial per carton	1 vial per carton
NDC	0069-0308-01	0069-0305-01
WAC	$1,211.10	$3391.08
Q-Code	Q5116: Injection, trastuzumab-qyyp, biosimilar (Trazimera, 10 mg)

Note: WAC price is a manufacturer’s undiscounted price and is not inclusive of contracts, rebates, or other discounts.

 

Posted 3/12/2021

 

 

On behalf of Pfizer, it is our pleasure to inform you that on February 9th, 2021, Pfizer received FDA approval for the inclusion of epithelial ovarian, fallopian tube, and primary peritoneal cancer to the indications of ZIRABEV^® (bevacizumab-bvzr).

There were also updates to align the ZIRABEV USPI with that of the reference product, AVASTIN incorporating revisions related to wound healing and the addition of adverse drug reactions, arterial aneurysms, dissections, and rupture to the Post Marketing Experience section.

ZIRABEV is currently the only bevacizumab biosimilar to be granted approval for epithelial ovarian, fallopian tube, and primary peritoneal cancer indications.

 

Please review the ZIRABEV Full Prescribing Information, including BOXED WARNINGS, for detailed information.

 

Product information is listed in the table below.

 

	ZIRABEV Product Information
Unit of Sale	100 mg/4 mL SDV	400 mg/16 mL SDV
Unit of Sale Quantity	1 vial per carton	1 vial per carton
NDC	0069-0315-01	0069-0342-01
WAC	$613.40	$2,453.60
Q-Code	Q5118: Injection, bevacizumab-bvzr, biosimilar (ZIRABEV), 10 mg

Note: WAC price is a manufacturer’s undiscounted price and is not inclusive of contracts, rebates, or other discounts.

 

Posted 3/12/2021

 

 

For more information please see the press release here and visit www.COSELA.com.

 

Posted 3/12/2021

 

Oncopeptides, Inc. is pleased to announce the FDA has granted approval for PEPAXTO® (melphalan flufenamide).

For more information, please see the full Prescribing Information and press release:  U.S. Press Release

 

Posted 3/5/2021

 

EMD Serono, Inc. is pleased to announce that on February 3, 2021 the U.S. Food and Drug Administration (FDA) approved TEPMETKO® (tepotinib). 

Please see Full Prescribing Information for TEPMETKO (tepotinib) for more information.

Posted 2/5/2021

 

Pfizer Oncology is proud to announce a new FDA-approved indication for XALKORI® (crizotinib) capsules. The following information is available for State Society review:

‐ Read the Full Prescribing Information

‐ Read the Press Release

If you should have any questions, please contact our ED, Alexandria Hafler and she will connect you with our representative. 

Posted 1/25/2021

 

Continuing our four decades of experience in biologics development, Amgen is proud to announce the availability of our latest biosimilar RIABNI™ (rituximab-arrx). Please click the link below to see full Prescribing Information, including Boxed WARNINGS:

RIABNI™ Prescribing Information 

The Wholesale Acquisition Cost (WAC) of RIABNI™ will be 23.7% lower than the reference product.  RIABNI^TM is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, 23.7% less than the WAC for Rituxan^®, 15.2% less than the WAC for TRUXIMA^®, and matching the WAC for RUXIENCE^®.  At launch, RIABNI^TM is priced 16.7% below the current Rituxan^® Average Selling Price (ASP).

 

RIABNI™ will be available from both wholesalers and specialty distributors.

 

Additionally, the following Healthcare Common Procedure Coding System (HCPCS) and National Drug Codes (NDC) have been assigned:

RIABNI™:

• Hospital HCPCS = C9399 (unclassified drugs or biologics)
• Clinic HCPCS = J3590 (unclassified biologic)
• NDC 55513-224-01, 100 mg single-dose vial of RIABNI™
• NDC 55513-326-01, 500 mg single-dose vial of RIABNI™

 

RIABNI^TM is administered as an intravenous infusion.

RIABNI™ Product Fact Sheet.

Posted 1/11/2021

 

UHC has delayed the Accumulator Adjustment Medical Benefit Program.

You can find their official announcement here.

Posted 11/13/2020

 

We wanted to share the United Healthcare Accumulator Adjustment Medical Benefit Program. This will go into effect on 1/1/21. Please click here for the full detailed protocol.  

CHOP recognizes the hardship this program may have on practice’s UHC beneficiaries and their access to medications.

Consequently, the CHOP Board has a call in early December with UHC to discuss this matter and other recent policy changes.

Posted 11/11/2020

 

Today is World NET Day coordinated by the International Neuroendocrine Cancer Alliance (INCA). Their mission: raise awareness about all types of NETs; push for scientific advancements with a focus on unmet needs; and to provide a platform for global collaboration to address many challenges NET patients and the medical community face.

Learn more about their efforts: https://incalliance.org/net-cancer-day/

#NETCancerDay

 Posted 11/10/2020