03/22/2020

PURCHASE YOUR TICKETS NOW AND SAVE THE NEW DATE

JALBCA’s Annual Awards Presentation Dinner Rescheduled

Date: September 8, 2020 – NEW DATE
Place: Ziegfeld Ballroom
141 West 54th Street
New York, NY 10019

Time: 6pm Cocktails | 7pm Dinner

At the dinner, JALBCA will be honoring:

• Honorable Jenny Rivera, Associate Judge of the New York Court of Appeals – Leadership Achievement Award
• The IBM Legal Department – Maite Aquino Memorial Grant Award
• Judith Livingston for her many years of service to JALBCA

For more information about the event please go to:
https://jalbca.org/events/jalbcas-annual-awards-presentation-dinner-2020/
To purchase tickets please go to:
https://jalbcadinner2020.eventbrite.com

JALBCA’s JANUARY 2020 MEMBERSHIP RECEPTION

On January 13, JALBCA held its inaugural membership reception, hosted by Robinson & Cole. The event was organized by the Membership Committee, led by Co-Chairs Virginia Trunkes and Hon. Donna Golia. The event was fun for all and a great success. We welcome all new JALBCA members who joined after the event.

NEWS BRIEF – FDA UPDATE ON CANNABIS OR CANNABIS-DERIVED COMPOUNDS

Background

Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Many people are aware of the prospect of using cannabis or cannabis-derived compounds, including CBD, in connection with cancer treatment.

On January 16, 2020, the House Energy and Commerce Subcommittee on Health held a legislative hearing, entitled Cannabis Policies for the New Decade. The meeting was intended to examine federal cannabis policy, including the implications of rescheduling cannabis to a less restrictive category (i.e., less restrictive than Schedule 1 under the Controlled Substances Act, which categorizes cannabis with drugs such as heroin) and the potential of cannabis research.

Presently, 33 states plus the District of Columbia have legalized medical marijuana and 11 states permit adult-use cannabis consumption. Each state has different laws covering qualifying conditions and dispensing of medical marijuana. (Federal Marijuana Policy Hearing Makes Progress at https://www.forbes.com/sites/sarabrittanysomerset/2020/01/16/federal-marijuana-policy-hearing-makes-progress/#56d9b0a54370)

General Medical Claims About Cannabis in Relation to Cancer

Some studies involving individuals undergoing cancer treatment have shown that medical marijuana can help to manage the following:

• Pain – marijuana can work similarly to opioids. In addition, the claim is that it may have anti-inflammatory effects that can help with pain.
• Neuropathy – marijuana relieves the pain from neuropathy (nerve damage) that is a common complication of chemotherapy and other cancer treatments and is characterized by symptoms such as a feeling of weakness, numbness, tingling, or burning in the hands and feet.
• Nausea and vomiting – medical marijuana can be an effective treatment for nausea and vomiting, which are side effects of chemotherapy. There are many medications available to treat this symptom. Dronabinol is a synthetic cannabinoid that is approved by the FDA for the nausea and vomiting that is a side effect of chemotherapy.
• Anorexia or cachexia – marijuana may improve appetite. Cancer is associated with anorexia (the medical term for loss of appetite) and cachexia and wasting syndrome (unintentional weight loss, specifically the loss of lean muscle and fat). It is often accompanied by fatigue and a decline in functional abilities. Dronabinol is FDA-approved for anorexia associated with AIDS but not specifically for cancer.
• Anti-neoplastic – pre-clinical studies (lab and animal testing) show that marijuana may be effective in slowing down or stopping the growth of certain tumors.

See: Medical Marijuana and Cancer at https://www.cancercare.org/publications/328-medical_marijuana_and_cancer.

FDA Consumer Update November 2019

In November 2019, the FDA published a consumer update on its ongoing analysis of the safety of these products. The FDA also issued warning letters to 15 companies for selling CBD-containing products in violation of the Food, Drug, and Cosmetic Act (FD&C Act). The following summarizes some of the items covered in the FDA’s publication and warning letters. See: FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

In its consumer update, the FDA identified several specific health risks potentially posed by CBD. The agency referenced the following: an association between CBD and the potential for liver injury; that CBD may impact the efficacy of other medications, while other medications might impact the potency of CBD products; an association between CBD and male reproductive toxicity in animals (and an effort by the FDA to learn if this risk would translate to humans). While consumers might be harmed by these risks without notice, there are risks that are readily detectable such as changes in alertness, gastrointestinal distress, and changes in mood – these should improve once CBD is stopped or reduced.

The FDA also advised consumers of the kinds of general risks that speak to concerns such as (1) marketing CBD with unproven medical benefits; (2) selling CBD products of unknown quality, where the items are marketed to have certain levels of CBD which they do not have; (3) reported claims (which are being investigated) of certain CBD products that might also contain THC or unsafe contaminants like pesticides or heavy metals.

The FDA’s position presently remains that it is an illegal act under Federal law (1) to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added or (2) to sell THC or CBD products as dietary supplements. It has concluded, based on available evidence, that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)].

The agency claims a need for more high-quality scientific information about the safety of CBD. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products – there are no other FDA-approved drug products that contain CBD. These approved products are only available with a prescription from a licensed healthcare provider.

FDA Warning Letters

FDA issued warning letters to 15 companies across several different states for illegally selling CBD-containing products. Each of these companies made claims that its products could be used to treat serious diseases. Certain of the letters were directed to CBD products that not only were marketed with serious disease claims but were also marketed to particularly vulnerable populations like infants and children, as well as CBD products that are intended for food-producing animals, which might affect human food products derived from those animals.

The Role of Congress

The FDA stated that it is “committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products”. This is consistent with the urging by Congress for that agency to find such a pathway in light of the fact that 2018 Farm Bill (the Agriculture Improvement Act of 2018, Pub. L. 115-334) legalized hemp and CBD from hemp. Cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.

Possible Ways to Access Cannabis or Cannabis-Derived Products for Medical Use

The FDA provided information on how patients can gain access to these products through “expanded access” (a/k/a compassionate use) – a pathway to try an investigational medical product (drug, biologic, or medical device) when a patient has a serious or life-threatening disease or condition. This is done outside of clinical trials when there are no comparable or satisfactory therapies available. Second, the FDA provided information for patients to gain access to these products through Right to Try, which is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors. The Right to Try Act (Public Law 115-176 ) was signed into law on May 30, 2018 and provides patients, who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options and who are unable to participate in a clinical trial, access to certain unapproved treatments.

More information about these two potential methods of access is available at FDA websites. For information about expanded access, see https://www.fda.gov/news-events/public-health-focus/expanded-access. For information about the Right to Try Act, see https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try.

ANNOUNCEMENTS

Breast Cancer Test Results – Key Takeaways from the ASCO Meeting

The American Society of Clinical Oncology will hold its annual meeting this year May 29, 2020 to June 2, 2020. The venue for the meeting will be McCormick Place Convention Center, Chicago IL. The annual meeting brings together oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. If interested in more information, go to this link: https://www.asco.org/calendar.

Key takeaways from the 2019 meeting, relating to breast cancer, were summarized in the July 19, 2019 issue of the ASCO Daily News, as reported by two experts, Hope Rugo, MD, FASCO, of the University of California, San Francisco, and Pavani Chalasani, MD, MPH, of the University of Arizona College of Medicine. In that article, test results from the following studies were described:

KRISTINE – compared trastuzumab-emtansine plus pertuzumab to trastuzumab, pertuzumab, and chemotherapy (THCP) in 444 women with HER2-positive stage II or III breast cancer
Result: study demonstrated a significantly better event-free survival rate at 36 months in the THCP cohort

Patient-Reported Outcomes in NRG Oncology/NSABP B-39/RTOG 0413 – studied long-term survival rates and recurrence risk in women with low-risk, early-stage breast cancer who received partial-breast irradiation (PBI) compared with those who received whole-breast irradiation
Result: study found similar long-term survival rates and recurrence risk in the two groups. Also, participants who received PBI reported less fatigue, whether or not they underwent post-PBI chemotherapy

NALA –Phase III trial which compared neratinib and capecitabine against lapatinib and capecitabine in patients with HER2-positive metastatic breast cancer previously treated with two or more HER2-directed regimens
Result: the neratinib cohort demonstrated significantly improved progression-free survival (PFS) with a trend toward improved overall survival, as well as a delayed time to intervention for symptomatic central nervous system disease

SOPHIA – Phase III study which compared margetuximab/chemotherapy to trastuzumab/chemotherapy in patients with HER2-positive metastatic breast cancer after prior anti-HER2 therapies
Result: demonstrated a small, although statistically significant, one month difference in PFS and some improvement in clinical benefit rates

FAKTION –Phase II study which compared the AKT inhibitor capivasertib plus fulvestrant to placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER-positive breast cancer
Result: showed a doubling in PFS in the capivasertib group – demonstrates the benefits of AKT inhibitors in patients with AKT or P13K pathway mutations

MONALEESA-7 –Phase II trial of ribociclib with or without endocrine therapy in premenopausal patients with HR-positive/HER2-negative advanced breast cancer
Result: demonstrated a 29% relative reduction in the risk of death in the ribociclib group—the first time a statistically significant overall survival has been seen with a CDK4/6 inhibitor in this patient population

HERITAGE – study of biosimilars, it compared the biosimilar trastuzumab-dkst (Ogivri) to trastuzumab after combination therapy
Result: there were similar outcomes in PFS and overall survival at 36 months between the two arms, arguably validating the whole field of biosimilars

CLEOPATRA– study compared first-line pertuzumab, trastuzumab, and docetaxel in patients with HER2-positive metastatic breast cancer against placebo, trastuzumab, and docetaxel
Result: continued to demonstrate significant overall survival in the pertuzumab arm, with a median overall survival at 8 years of 57.1 months (37% of patients) compared to 40.8 months in the placebo arm (23%)

Impassion130 – study randomly assigned patients with previously untreated locally advanced or metastatic triple-negative breast cancer to atezolizumab plus nab-paclitaxel or placebo plus nab-paclitaxel
Result: demonstrated a continued improvement in overall survival

For more information, see: https://dailynews.ascopubs.org/do/10.1200/ADN.19.190366/full/.