Resources for For Clinicians

Ado-trastuzumab emtansine (Kadcyla®)

• Received prior therapy for metastatic disease, or
• Developed disease recurrence during or within six months of completing adjuvant therapy

• Drug description
• Ado-trastuzumab emtansine (Kadcyla®)

Belantamab mafodotin (Blenrep™)

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The recommended dosage is 2.5 mg/kg as an intravenous infusion over approximately 30 minutes once every 3 weeks (Q3W)

• Belantamab mafodotin (Blenrep™)
• Blenrep REMS (Risk Evaluation and Mitigation Strategy)
• Access & reimbursement enrollment form (United States Only)

Brentuximab Vedotin (Adcetris®)

• Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
• Classical HL at high risk of relapse or progression as post auto-HSCT consolidation treatment.
• Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
• The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Brentuximab Vedotin
• Brentuximab Vedotin (Updates)

Enfortumab Vedotin-ejfv (Padcev™)

This indication is approved under accelerated approval based on the tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Enfortumab vedotin-ejfv (Padcev™) / HCP
• Patient Assistant Program

English

English

Fam-trastuzumab deruxtecan-nxki (Enhertu®)

The HER2 directed antibody-drug conjugate is approved for the treatment of adult patients with advanced, unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based treatments in the metastatic setting.

* Fam-trastuzumab deruxtecan-nxki in the US only, trastuzumab deruxtecan outside the United States.

• Fam-trastuzumab deruxtecan-nxki (Enhertu®) – Patient Information
• Fam-trastuzumab deruxtecan-nxki (Enhertu®) – HCP

English

English

Gemtuzumab Ozogamicin (Mylotarg®)

• Gemtuzumab Ozogamicin

Inotuzumab Ozogamicin (Besponsa®)

• Inotuzumab Ozogamicin

Polatuzumab Vedotin-piiq (Polivy™)

• Polatuzumab vedotin-piiq (Polivy™)

Sacituzumab Govitecan-hziy (Trodelvy™)

In April 2020, sacituzumab govitecan received accelerated approval from the U.S. Food and Drug Administration for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

Sacituzumab govitecan is undergoing phase III development for breast cancer in the United States and Europe, and phase II development for urothelial cancer.

The drug is also being explored for brain metastases, glioblastoma, endometrial cancer, and prostate cancer.

• Sacituzumab Govitecan-hziy (Trodelvy™)

Loncastuximab tesirine-lpyl (Zynlonta^®)

Mechanism of Action
Upon binding to CD19, Loncastuximab tesirine-lpyl  is internalized into the tumor cell and the PBD dimer cytotoxin is released into the cell. The PBD dimer—an alkylating agent—binds to the DNA minor groove and forms highly cytotoxic DNA interstrand crosslinks. DNA interstrand crosslinks subsequently induce tumor cell death¹

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• Loncastuximab tesirine-lpyl (Zynlonta^®)

Tisotumab vedotin-tftv (Tivdak® )

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Tisotumab vedotin-tftv (Tivdak® )

Mirvetuximab Soravtansine-gynx (Elahere®)

Mirvetuximab soravtansine (Elahere®; previously known as IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

The US Food and Drug Administration (FDA) granted accelerated approval for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Mirvetuximab soravtansine was approved under FDA’s accelerated approval program based on objective response rate (ORR) and duration of response (DOR) data from the pivotal SORAYA trial. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Mirvetuximab soravtansine is a first-in-class ADC directed against FRα, a cell-surface protein highly expressed in ovarian cancer, and is the first FDA approved ADC for platinum-resistant disease.

History
In June 2018, the FDA granted mirvetuximab Fast Track designation for the treatment of patients with medium to high FRα-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. This designation is intended to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions.

In December 2019, the Company (ImmunoGen) announced that FDA advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab. Based on this guidance, the Company initiated SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with FRα-high platinum-resistant ovarian cancer who have been previously treated with bevacizumab (Avastin®; Genentech/Roche). Positive top-line data for SORAYA was announced in November 2021.

Confirmation studies
ImmunoGen is concurrently enrolling MIRASOL, the Phase 3 randomized confirmatory study of mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer who have been treated with up to three prior regimens. Mirvetuximab monotherapy is also being studied in later line platinum-sensitive ovarian cancer and in combination in both platinum-resistant and platinum-sensitive disease.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Mirvetuximab soravtansine (Elahere®)