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Coronavirus Doesn’t Halt Cancer Drug Approvals

Coronavirus Doesn’t Halt Cancer Drug Approvals
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Published on June 4, 2020

Amid the coronavirus outbreak, it’s been nothing but nonstop activity at the U.S. Food and Drug Administration (FDA): approving rapid tests, reviewing hundreds of inquiries and proposals related to drug development, and issuing the emergency use authorizations of various treatments and medical devices.

Rest assured cancer has not been forgotten.

Over the past two months, the FDA has approved several new cancer drugs. Some are new indications for already-approved drugs. Here’s a roundup of some of them below.

Talk to your healthcare provider about whether any of these treatments may be appropriate for you.

Breast Cancer

Drug: tucatinib (Tukysa) tablets in combination with trastuzumab (Herceptin) and capecitabine (Xeloda)

Manufacturer: Seattle Genetics

Date Approved: April 17, 2020

Who Benefits: Adult patients with previously treated inoperable or metastatic HER2-positive breast cancer, including cancer that has spread to the brain.

What they’re saying: “… the addition of Tukysa to trastuzumab and capecitabine has the potential to become a standard of care for people with HER2-positive metastatic breast cancer after having received one or more previous anti-HER2 therapies in the metastatic setting,” said Dr. Eric Winer, chief of the division of breast oncology at Dana-Farber Cancer Institute in Boston.

Drug: sacituzumab govitecan-hziy (Trodelvy) injection

Manufacturer: Immunomedics

Date Approved: April 22, 2020

Who Benefits: Adult patients with metastatic triple-negative breast cancer (mTNBC) that has worsened despite two previous rounds of treatment.

What they’re saying: “In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle toward better outcomes for patients with metastatic breast cancer,” said lead investigator Dr. Aditya Bardia of the Center for Breast Cancer at Massachusetts General Hospital Cancer Center in Boston.

Chronic Lymphocytic Leukemia (CLL)

Drug: ibrutinib (Imbruvica) tablets/capsules in combination with antibody therapy rituximab (Rituxan)

Manufacturer: AbbVie and Johnson & Johnson (Imbruvica); Roche (Rituxan)

Date Approved: April 21, 2020

Who Benefits: Previously untreated adult patients with CLL or small lymphocytic lymphoma (SLL).

What they’re saying: “With the introduction of this ibrutinib-rituximab combination, patients now have a more effective, non-chemoimmunotherapy option," said Dr. Brian Koffman, co-founder and chief medical officer of the CLL Society. "In the 14 years since I was first diagnosed with CLL, the treatment landscape has advanced dramatically for the better…."

Lung Cancer

Drug: capmatinib (Tabrecta) tablets

Manufacturer: Novartis

Date Approved: May 6, 2020

Who Benefits: Adult patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14). METex14 has been linked to cancer growth in mNSCLC.

What they’re saying: “In our quest to reimagine medicine, we have worked tirelessly over the past decades to advance the understanding and treatment of NSCLC, striving to make a difference in patients’ lives, one mutation at a time,” said Dr. Susanne Schaffert, president of Novartis Oncology.

Drug: selpercatinib (Retevmo) capsules

Manufacturer: Loxo Oncology, Inc., a subsidiary of Eli Lilly and Company.

Date Approved: May 8, 2020

Who Benefits: Adults patients with RET (rearranged during transfection)-positive mNSCLC and two types of advanced thyroid cancer. RET rearrangement (a rare alteration in the RET gene) is detected in 1 percent to 2 percent of NSCLC patients.

What they’re saying: “In the clinical trial, we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases,” said Dr. Alexander Drilon of Memorial Sloan Kettering Cancer Center in New York City.

Drug: brigatinib (Alunbrig) tablets 

Manufacturer: Takeda

Who Benefits: Adult patients with ALK+ mNSCLC.

Date Approved: May 22, 2020

What they’re saying: “Having this option for newly diagnosed patients is exciting news for the ALK+ NSCLC community and adds to the remarkable progress we have witnessed in lung cancer treatment over the past decade,” said Andrea Stern Ferris, president and CEO of the LUNGevity Foundation.

Drug: nivolumab (Opdivo) plus ipilimumab (Yervoy) injections and 2 cycles of chemotherapy

Manufacturer: Bristol Myers Squibb Co.

Date Approved: May 26, 2020

Who Benefits: Adult patients with previously untreated metastatic or recurrent NSCLC, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, regardless of PD-L1 expression.

What they’re saying: “We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients’ long-term outcomes,” said Dr. David P. Carbone, study investigator and director of the James Thoracic Oncology Center at The Ohio State University in Columbus. “…more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life.”

Prostate Cancer

Drug: olaparib (Lynparza) tablets/capsules

Manufacturer: AstraZeneca and Merck

Date Approved: May 20, 2020

Who Benefits: Adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) following progression on enzalutamide (Xtandi) or abiraterone acetate (Zytiga). HRR gene mutations occur in approximately 20 to 30 percent of patients with mCRPC.

What they’re saying: “Prostate cancer has lagged behind other solid tumors in the era of precision medicine,” said Dr. Maha Hussain, one of the principal investigators and deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Evanston, Illinois. “I am thrilled by the approval of Lynparza, which now brings a molecularly targeted treatment for this patient population in the U.S.”

Drug: rucaparib (Rubraca) tablets

Manufacturer: Clovis Oncology

Date Approved: May 15, 2020

Who Benefits: Adult patients with BRCA-mutated mCRPC who have been treated with an androgen receptor-directed therapy and a taxane-based chemotherapy.

What they’re saying: “Given the level and duration of responses observed with Rubraca in men with mCRPC and these mutations, it represents an important and timely new treatment option for this patient population,” said Dr. Wassim Abida, medical oncologist at Memorial Sloan Kettering Cancer Center in New York City and principal investigator of the study. 

~Megan Trusdell

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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