On March 7, 2022 Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its fourth quarter and full year 2021 financial results and highlighted recent corporate achievements (Press release, Day One, MAR 7, 2022, View Source [SID1234609618]).

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"Our clinical and corporate achievements in 2021 have set a solid foundation for a potentially transformational next 12 months," said Jeremy Bender, Ph.D., chief executive officer of Day One. "We expect to report the initial data from our pivotal Phase 2 FIREFLY-1 trial of DAY101 in relapsed pediatric low-grade glioma in June of 2022 followed by topline results in the first quarter of 2023. In addition, we are enrolling patients in our Phase 2 FIRELIGHT-1 monotherapy trial of DAY101 in RAF-altered solid tumors and are preparing to initiate a Phase 1b/2 combination portion of the study with our oral MEK inhibitor, pimasertib. As our clinical development programs continue to advance and expand, we remain well-capitalized to fund our operations into 2024 and we will continue to execute on our mission to provide innovative targeted therapies for people of all ages."

Program Highlights

•Initial data from FIREFLY-1, a pivotal Phase 2 clinical trial of DAY101 (tovorafenib) in pediatric low-grade glioma (pLGG), is expected in June 2022.

•FIREFLY-1 has reached targeted enrollment across approximately 30 sites globally. Day One anticipates releasing topline results from the study in the first quarter of 2023. Pending positive results from FIREFLY-1, Day One anticipates filing a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2023.

•The first patient has been dosed with a pediatric formulation in the FIREFLY-1 study.

•The Company plans to initiate a pivotal Phase 3 clinical trial (FIREFLY-2) evaluating DAY101 as a first-line therapy in pLGG in the second quarter of 2022.

•Day One is enrolling patients in the Phase 2 FIRELIGHT-1 trial evaluating DAY101 monotherapy in adults with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations, with 8 sites activated. Day One plans to expand FIRELIGHT-1 to include a Phase 1b/2 portion to evaluate DAY101 in combination with pimasertib, the Company’s MEK Inhibitor. The Company expects to initiate the combination portion of the study in March of 2022.

Fourth Quarter and Full Year 2021 Financial Highlights

•Cash Position: Cash and cash equivalents totaled $284.3 million on December 31, 2021. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2024.

•R&D Expenses: Research and development expenses were $11.2 million and $43.6 million for the fourth quarter and full year ended December 31, 2021, respectively, as compared to $4.2 million and $9.1 million for the same periods in 2020. The increase was primarily due to additional employee compensation costs, milestone payments for licensing agreements, clinical trial, and product development expenses.

•G&A Expenses: General and administrative expenses were $10.8 million and $29.2 million for the fourth quarter and full year ended December 31, 2021, respectively, as compared to $2.0 million and $4.7 million for the same periods in 2020. The increase was primarily due to additional employee compensation costs, legal, and professional expenses associated with operating as a public company.

•Net Loss: Net loss totaled $21.9 million for the fourth quarter of 2021 with non-cash stock compensation expense of $5.1 million, compared to $35.6 million for the fourth quarter of 2020 with non-cash stock compensation expense of $0.4 million. Net loss was $72.8 million for the year ended December 31, 2021, with non-cash stock compensation expense of $13.3 million, compared to $43.8 million for the year ended December 31, 2020, with non-cash stock compensation expense of $0.5 million.

Upcoming Events

•Cowen 42nd Annual Health Care Conference
oManagement will participate in a fireside chat today, March 7 at 2:50 p.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events & Presentations section of the Company’s website.

About DAY101 (tovorafenib)

DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway. Studies have shown DAY101 has high brain distribution and exposure in comparison to other MAPK pathway inhibitors, thus potentially benefiting patients with primary brain tumors or brain metastases of solid tumors. DAY101 is a type II RAF inhibitor found to selectively inhibit both monomeric and dimeric RAF kinase.

DAY101 has been studied in over 250 patients, and as a monotherapy, previously demonstrated good tolerability and encouraging anti-tumor activity in pediatric and adult populations with specific MAPK pathway-alterations. DAY101 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options. The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children. In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

DAY101 is being evaluated in a pivotal Phase 2 clinical trial (FIREFLY-1) for the treatment of pediatric low-grade glioma (pLGG). pLGG is the most common form of childhood brain cancer with no approved therapies. Day One has also initiated a Phase 1b/2 study (FIRELIGHT-1) with DAY101 in patients with recurrent or progressive solid tumors with activating RAF alterations and additional studies are planned with DAY101 alone or in combination with other agents that target key signaling nodes in the MAPK pathway, such as the Company’s MEK inhibitor pimasertib, in patient populations where RAS and RAF alterations are believed to play an important role in driving disease.

On March 7, 2022 Nectin Therapeutics Ltd., (Nectin) a biotechnology company developing novel targeted immunotherapies that address resistance to approved immune oncology treatments, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) to provide funding and clinical expertise to advance promising cancer therapies, reported a Cancer Focus Fund investment of $5.4 million to finance a Phase 1 clinical trial of Nectin’s PVR blocker, NTX1088, in cancer patients with locally advanced and metastatic solid tumors (Press release, Nectin Therapeutics, MAR 7, 2022, View Source [SID1234609616]).

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NTX1088 is a high affinity monoclonal antibody directed against PVR, an immune checkpoint ligand. NTX1088 blocks the signaling of the immune checkpoint receptors TIGIT and CD96, while restoring the expression and immune function of DNAM1 (CD226), resulting in increased anti-tumor immune effects from activated T cells and natural killer (NK) cells in the tumor microenvironment. PVR is overexpressed in many solid tumors across different cancer indications, including lung, colorectal, liver, ovarian, breast, adrenal, pancreatic, uterine, head and neck, gastric and esophageal. High PVR expression is associated with poor prognosis and with resistance to PD1 blockade, making PVR an attractive therapeutic target for novel immuno-oncology therapies, both as a monotherapy and in combination with PD1 blockers.

The Cancer Focus Fund investment will support a Phase 1 clinical study at MD Anderson, assessing NTX1088 in the treatment of locally advanced and metastatic solid tumors. Cancer Focus Fund is receiving a combination of equity and future payments from Nectin based on achievement of certain clinical and commercial milestones.

"Cancer Focus Fund is committed to advancing the clinical development of novel cancer therapies with the potential to have a significant impact on patients," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "Despite their early promise, the majority of cancer patients do not respond to, or eventually acquire resistance to, current immunotherapies. NTX1088 has a unique mechanism of action that works in three ways to suppress the immune inhibitory effects of tumors while also promoting direct anti-tumor activity. We are delighted to help fund this first-in-human clinical trial at MD Anderson, our collaborator in leading Cancer Focus Fund-financed clinical trials."

The Phase 1 trial is an open label study in 90 patients that will be conducted in two stages – a dose escalation stage and an expansion stage. NTX1088 will be investigated as a single agent and in combination with a PD1 blocker. The primary objectives of the dose escalation stage is to assess safety and tolerability and to select a recommended safe and effective dose. In the expansion stage of the trial, NTX1088’s safety and tolerability will be further evaluated, along with initial efficacy measures and exploratory assessments of pharmacodynamic and predictive biomarkers, which will assist in stratifying patients moving forward. Sarina A. Piha-Paul, MD, an Associate Professor in the Department of Investigational Cancer Therapeutics at MD Anderson, will serve as the Principal Investigator.

"Nectin Therapeutics is developing a portfolio of innovative anticancer compounds directed at highly differentiated targets within the nectin family of immune checkpoints," said Fabian Tenenbaum, Chief Executive Officer of Nectin Therapeutics. "The upcoming initiation of our first-in-human clinical trial is a major milestone for the company. We welcome the financial support from Cancer Focus Fund and clinical expertise of MD Anderson in facilitating the Phase 1 study for this promising new approach to helping patients mount an effective immune response to their cancer."

The Phase 1 trial is expected to begin enrolling patients around mid-year of 2022.

About NTX1088
NTX1088 is a first-in-class monoclonal antibody directed against a key immune checkpoint, PVR, also known as CD155. NTX1088 has a triple mechanism of action. It binds PVR with high affinity and blocks its interactions with TIGIT and CD96, preventing their immune inhibitory signaling. NTX1088 also blocks the interaction between PVR and DNAM1, also known as CD226, a molecule involved in the activation of anti-cancer T cells and NK cells. By preventing internalization and degradation of DNAM1, NTX1088 leads to restoration of DNAM1 expression on the surface of immune cells and results in robust antitumor activity. NTX1088 demonstrated superior antitumor activity compared to approved and investigational immune checkpoint inhibitors in preclinical models and revealed a favorable safety profile in non-human primates.

On March 7, 2022 Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML) (Press release, Servier, MAR 7, 2022, View Source [SID1234609615]). The sNDA was granted Priority Review, which accelerates the review and shortens the review time goal from 10 months to 6 months. Priority Review is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.

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"On the heels of our recent FDA approval of TIBSOVO in cholangiocarcinoma, we are pleased with this important step forward in the agency’s consideration to expand its current indication to include the treatment of patients with previously untreated IDH1-mutated acute myeloid leukemia," said David K. Lee, Chief Executive Officer, Servier Pharmaceuticals. "We are thrilled with the positive momentum of this program as we continue to grow our leadership in oncology and deliver more life-changing medicines to patients living with difficult-to-treat cancers."

The sNDA acceptance is supported by results from the AGILE study, a global, Phase 3 trial in patients with previously untreated IDH1-mutated AML, which were presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The data demonstrated that treatment with TIBSOVO in combination with azacitidine significantly improved event-free survival (EFS) (hazard ratio [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). In addition, the combination of TIBSOVO with azacitidine showed a statistically significant improvement in overall survival (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), with a median OS of 24.0 months.

"TIBSOVO is the first therapy targeting cancer metabolism to demonstrate improved event-free survival and overall survival in combination with azacitidine in patients with previously untreated IDH1-mutated AML," said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. "With this FDA acceptance for Priority Review, we are closer to offering this critical treatment option to patients in the U.S. and we look forward to engaging with regulatory agencies around the world."

TIBSOVO[*] is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML), and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Recently, TIBSOVO was approved as a first and only targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma.

In an effort to bring innovative treatment options to patients living with difficult-to-treat cancers, Servier has made oncology a priority globally, and allocates more than 50% of its research and development budget to cancer research. With more than 21 oncology assets at varying stages of clinical development, and 20 research projects ongoing, Servier is committed to finding solutions that address patient needs across the entire spectrum of disease and in a variety of tumor types.

About the NCT03173248 AGILE Phase 3 AML Trial

The AGILE trial is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO in combination with azacitidine compared with placebo in combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy). The study’s primary endpoint is EFS, defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure is defined as failure to achieve complete remission (CR) by Week 24.

Key secondary endpoints included CR rate, defined as the proportion of participants who achieve a CR; overall survival (OS), defined as the time from date of randomization to the date of death due to any cause; CR and complete remission with partial hematologic recovery (CRh) rate, defined as the proportion of participants who achieve a CR or CRh; and objective response rate (ORR), defined as the rate of CR, CR with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery [CRp]), partial remission (PR), and morphologic leukemia-free state (MLFS).

About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults, with approximately 20,000 new cases in the U.S., and 43,000 cases in Europe each year.1,2,7 AML incidence significantly increases with age, and the median age of diagnosis is 68.1 The vast majority of patients do not respond to chemotherapy and progress to relapsed/refractory AML.3 The five-year survival rate is approximately 29.5%.1 For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia.4

On March 7, 2022 Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company dedicated to the development of innovative antibody drugs, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the IND application for the initiation of the open-label, multicenter phase II trial in China using Cadonilimab (PD-1/CTLA-4 bispecific antibody, AK104) in combination with Docetaxel in patients with advanced NSCLC which progressed on combination therapy of PD-1/L1 inhibitor and platinum-based doublet chemotherapy (Press release, Akeso Biopharma, MAR 7, 2022, View Source [SID1234609614]).

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PD-1/L1 inhibitor plus chemotherapy serves as the first-line treatment for patients with advanced NSCLC. However, more than 70% of patients have progressed one year following the therapy. The current standard treatment for progressive advanced NSCLC is Docetaxel, which the reported progression-free survival (PFS) was approximately 4 months, and overall survival (OS) was approximately 10 months. A new therapeutic approach is needed to improve the prognosis of patients.

Cadonilimab is a bi-specific antibody with dual blockade of both PD-1 and CTLA-4. By combining with Docetaxel, this combo strategy may reduce the risk of delayed efficacy and pseudoprogression and may benefit patients with advanced NSCLC following PD-1/L1 inhibitor and platinum-based doublet chemotherapy.

On March 7, 2022 Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), reported the launch of a first generic version of Revlimid1 (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States (Press release, Teva, MAR 7, 2022, View Source [SID1234609612]).

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Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following specific prior treatment. Please see the below "What are lenalidomide capsules?" section for more information.

"The launch of our first generic version of Revlimid in the U.S. provides patients with another important treatment option for these extremely challenging conditions, demonstrating Teva’s commitment to making complex generic drugs available to the patients who need them," said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. "This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization."

With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Revlimid had annual sales of $2.3 billion as of December 2021, according to IQVIA data.

What are lenalidomide capsules? Lenalidomide capsules are a prescription medicine, used to treat adults with:

multiple myeloma (MM)
in combination with the medicine dexamethasone
a condition called myelodysplastic syndromes (MDS). Lenalidomide capsules are for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.
mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 prior medicines, one of which included bortezomib. MCL is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.
Lenalidomide capsules should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.

It is not known if lenalidomide capsules are safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about lenalidomide capsules?

Before you begin taking lenalidomide capsules, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing lenalidomide capsules, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form.

Lenalidomide capsules may cause serious side effects including:

Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take lenalidomide capsules.

Lenalidomide is similar to the medicine thalidomide. We know thalidomide can cause severe life-threatening birth defects. Lenalidomide capsules have not been tested in pregnant females. Lenalidomide capsules have harmed unborn animals in animal testing.
Females must not get pregnant:

For at least 4 weeks before starting lenalidomide capsules
While taking lenalidomide capsules
During any breaks (interruptions) in your treatment with lenalidomide capsules
For at least 4 weeks after stopping lenalidomide capsules
Females who can become pregnant:

Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.
If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping lenalidomide capsules.
Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with lenalidomide capsules.
If you had unprotected sex or if you think your birth control has failed, stop taking lenalidomide capsules immediately and call your healthcare provider right away.
If you become pregnant while taking lenalidomide capsules, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Customer Care Center at 1‐888‐423‐5436. Healthcare providers and patients should report all cases of pregnancy to:

FDA MedWatch at 1-800-FDA-1088, and
The Lenalidomide REMS program at 1‐888‐423‐5436
There is a pregnancy exposure registry that monitors the outcomes of females who take lenalidomide capsules during pregnancy, or if their male partner takes lenalidomide capsules and they are exposed during pregnancy. You can enroll in this registry by calling the Lenalidomide REMS program at the phone number listed above.

Lenalidomide can pass into human semen:

Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking lenalidomide capsules, during any breaks (interruptions) in your treatment with lenalidomide capsules, and for up to 4 weeks after stopping lenalidomide capsules.
Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.
Do not donate sperm while taking lenalidomide capsules, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping lenalidomide capsules. If a female becomes pregnant with your sperm, the baby may be exposed to lenalidomide and may be born with birth defects.
Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

Low white blood cells (neutropenia) and low platelets (thrombocytopenia). Lenalidomide capsules cause low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often especially during the first several months of treatment with lenalidomide capsules, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising, during treatment with lenalidomide capsules.
Blood clots. Blood clots in the arteries, veins, and lungs happen more often in people who take lenalidomide capsules. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with lenalidomide capsules. Heart attacks and strokes also happen more often in people who take lenalidomide capsules with dexamethasone. To reduce this increased risk, most people who take lenalidomide capsules will also take a blood thinner medicine.
Before taking lenalidomide capsules, tell your healthcare provider:

If you have had a blood clot in the past
If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)
About all the medicines you take. Certain other medicines can also increase your risk for blood clots. Call your healthcare provider or get medical help right away if you get any of the following during treatment with lenalidomide capsules:
Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling
Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting
Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance
Who should not take lenalidomide capsules?

Do not take lenalidomide capsules if you:

are pregnant, plan to become pregnant, or become pregnant during treatment with lenalidomide capsules. See "What is the most important information I should know about lenalidomide capsules?"
are allergic to lenalidomide or any of the ingredients in lenalidomide capsules. See the end of the Medication Guide for a complete list of ingredients in lenalidomide capsules.
What should I tell my healthcare provider before taking lenalidomide capsules?

Before you take lenalidomide capsules, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have kidney problems or receive kidney dialysis treatment
have thyroid problems
have had a serious skin rash with thalidomide treatment. You should not take lenalidomide capsules.
are lactose intolerant. Lenalidomide capsules contain lactose.
are breastfeeding. Do not breastfeed during treatment with lenalidomide capsules. It is not known if lenalidomide passes into your breast milk and can harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lenalidomide capsules and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

What should I avoid while taking lenalidomide capsules?

See "What is the most important information I should know about lenalidomide capsules?"
Females: Do not get pregnant and do not breastfeed while taking lenalidomide capsules.
Males: Do not donate sperm.
Do not share lenalidomide capsules with other people. It may cause birth defects and other serious problems.
Do not donate blood while you take lenalidomide capsules, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping lenalidomide capsules. If someone who is pregnant gets your donated blood, her baby may be exposed to lenalidomide and may be born with birth defects.
What are the possible side effects of lenalidomide capsules?

Lenalidomide capsules can cause serious side effects, including:

See "What is the most important information I should know about lenalidomide capsules?"
Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take lenalidomide capsules have an increased risk of death compared with people who take the medicine chlorambucil. Lenalidomide capsules may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take lenalidomide capsules if you have CLL unless you are participating in a controlled clinical trial.
Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received lenalidomide capsules and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs. Talk with your healthcare provider about your risk of developing new cancers if you take lenalidomide capsules. Your healthcare provider will check you for new cancers during your treatment with lenalidomide capsules.
Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with lenalidomide capsules. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:
yellowing of your skin or the white part of your eyes (jaundice
dark or brown (tea-colored) urine
pain on the upper right side of your stomach area (abdomen)
bleeding or bruising more easily than normal
feeling very tired
Severe skin reactions and severe allergic reactions can happen with lenalidomide capsules and may cause death.
Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with lenalidomide capsules:
a red, itchy, skin rash
peeling of your skin or blisters
severe itching
fever
Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with lenalidomide capsules:

swelling of your lips, mouth, tongue, or throat
trouble breathing or swallowing
raised red areas on your skin (hives)
a very fast heartbeat
you feel dizzy or faint
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking lenalidomide capsules: tender swollen lymph nodes, low grade fever, pain, or rash.
Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking lenalidomide capsules if you develop certain serious side effects during treatment with lenalidomide capsules.

Thyroid problems. Your healthcare provider may check your thyroid function before you start taking lenalidomide capsules and during treatment with lenalidomide capsules.
Risk of Early Death in MCL. In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking lenalidomide capsules. Talk with your healthcare provider about any concerns and possible risk factors.
The most common side effects of lenalidomide capsules include:

diarrhea
rash
nausea
constipation
tiredness or weakness
fever
itching
swelling of your arms, hands, legs, feet and skin
sleep problems (insomnia)
headache
muscle cramps or spasms
shortness of breath
cough, sore throat, and other symptoms of a cold
upper respiratory tract infection or bronchitis
inflammation of the stomach and intestine ("stomach flu")
nose bleed
shaking or trembling (tremor)
joint aches
pain in your back or stomach-area (abdomen)
These are not all the possible side effects of lenalidomide capsules. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the Medication Guide in the full Prescribing Information including Boxed Warning.