Genentech is pleased to announce that TECENTRIQ HYBREZA is FDA approved as the first subcutaneous checkpoint inhibitor, which means a faster
atezolizumab administration option is now available for you and your adult patients.

For the full press release, please click here.

NOW APPROVED

• In combination with palbociclib and fulvestrant
• For 1L HR+/HER2- mBC
• With PIK3CA mutation and endocrine resistance

Indication
Itovebi (inavolisib), in combination with palbociclib and fulvestrant, is indicated 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.

To access the entire packet, please click here!

Please review the update from BeiGene below to announce WAC pricing and that the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent drug-specific J-code TEVIMBRA (tislelizumab-jsgr) injection, for intravenous use, effective October 1, 2024. The J-code (J9329) and WAC are detailed in the attached link below.

Click here for more information.

VORANIGO was approved by the FDA to treat mIDH glioma. Please review the information and trial highlights below.

Click here for this update!

Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma
KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
 

View the complete new indication here.

Effective for dates of service on or after April 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has assigned the following Healthcare Common Procedure Coding System (HCPCS)* J-Code for ELREXFIO (elranatamab-bccm) injection:

J1323- Injection, elranatamab-bcmm, 1 mg

We are respectfully requesting that you update your membership about this important coding change for ELREXFIO (elranatamab-bccm).

Please see full prescribing information including Boxed Warning, HERE.

Merck would like to inform you that the FDA has approved WELIREG® (belzutifan) 40-mg tablets for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

To read the full press release, please click here!

Merck would like to inform you that the FDA has granted full approval to KEYTRUDA® (pembrolizumab) Injection
100 mg, in combination with enfortumab vedotin, and expanded the indication to:

• treatment of adult patients with locally advanced or metastatic urothelial cancer.

The combination initially received accelerated approval in April 2023 for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

To read the full release, please click here!

New oral treatment for adult patients with ROS1+ NSCLC. Find out more information here.

Additionally, you can review the press release by clicking here and access the US Prescribing Information by clicking here.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma.

Read the information here.

Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

Read the information here!

Adjuvant Treatment Following Resection and Platinum-Based Chemotherapy for Adult Patients With Stage IB
(T2a ≥4 cm), II, or IIIA NSCLC
KEYTRUDA® (pembrolizumab) Injection 100 mg, as a single agent, is indicated for adjuvant treatment following
resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non–small cell lung
cancer (NSCLC).
• PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients.
PD-L1=programmed death ligand 1.
SELECTED SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
• KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death
receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing
inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse
reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue,
can affect more than one body system simultaneously, and can occur at any time after starting treatment or after
discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible
severe and fatal immune-mediated adverse reactions.
• Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated
adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1
treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In
cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies,
including infection. Institute medical management promptly, including specialty consultation as appropriate.
• Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction.
In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to
2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less,
initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic
immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
• KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior
thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA,
including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were
required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36)
and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom
improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.
• Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single
agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions.
Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis
led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54%
interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.
Immune-Mediated Colitis
• KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/
reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of
corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immunemediated
colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade
3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional
immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA
in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after
symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.
Hepatotoxicity and Immune-Mediated Hepatitis
KEYTRUDA as a Single Agent
• KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of
patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic
corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in
11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9)
of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had
recurrence. Hepatitis resolved in 79% of the 19 patients.
SELECTED SAFETY INFORMATION (continued)
Severe and Fatal Immune-Mediated Adverse Reactions (continued)
Immune-Mediated Endocrinopathies
Adrenal Insufficiency
• KEYTRUDA® (pembrolizumab) can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate
symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending
on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade
4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22)
of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent
discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld
reinitiated KEYTRUDA after symptom improvement.
Hypophysitis
• KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated
with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism.
Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity.
Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3
(0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these,
the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in
0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom
improvement.
Thyroid Disorders
• KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy.
Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical
management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending
on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None
discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.
• Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and
Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients.
All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in
8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent
discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld
reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term
thyroid hormone replacement. The incidence of new or worsening hyperthyroidism was higher in 580 patients with
resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including
Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients
with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment
(KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.
Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis
• Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as
clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients
receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of
patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.
Immune-Mediated Nephritis With Renal Dysfunction
• KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of
patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic
corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in
0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom
improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.
Immune-Mediated Dermatologic Adverse Reactions
• KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson
syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–
PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate
nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated
dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%)
and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to
permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were
withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in
79% of the 38 patients.
SELECTED SAFETY INFORMATION (continued)
Severe and Fatal Immune-Mediated Adverse Reactions (continued)
Other Immune-Mediated Adverse Reactions
• The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless
otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD-1/
PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular:
Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic
syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune
neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated
with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in
combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome,
as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal:
Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and
Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis
(1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic
anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing
lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ
transplant rejection.
Infusion-Related Reactions
• KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis,
which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusionrelated
reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4
reactions, stop infusion and permanently discontinue KEYTRUDA.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
• Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD-1/PD-L1
treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic
GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome
(without an identified infectious cause). These complications may occur despite intervening therapy between anti–
PD-1/PD-L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene
promptly. Consider the benefit vs risks of using anti–PD-1/PD-L1 treatments prior to or after an allogeneic HSCT.
Increased Mortality in Patients With Multiple Myeloma
• In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone
resulted in increased mortality. Treatment of these patients with an anti–PD-1/PD-L1 treatment in this combination is
not recommended outside of controlled trials.
Embryofetal Toxicity
• Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.
Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating
KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.
Adverse Reactions
• The most common adverse reactions for KEYTRUDA as a single agent (reported in ≥20% of patients) were fatigue,
musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain,
abdominal pain, nausea, and hypothyroidism.
• Adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC
receiving KEYTRUDA as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and
pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.
Lactation
• Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during
treatment and for 4 months after the last dose.
Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information.
The Medication Guide also is available.
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
US-LAM-02598 02/23